EMPLOYMENT OPPORTUNITIES

Responsibilities:

• Excellent employment opportunity for a Manufacturing Associate in the Fremont, CA area.
• Perform production processes for GMP manufacturing operations.
• Execute routine unit operations in Purification such as chromatography, tangential flow filtration, Clean-In-Place (CIP), and Steam-In-Place (SIP) operations.
• Perform in-process analytical instrument measurements e.g. pH, conductivity, temperature, pressure, among others.
• Document execution of operations through the Bio Manufacturing Execution System (BioMES), batch record and equipment use logbook using Good Documentation Practices (GDP).
• Perform internal support duties including stocking consumables/materials, updating controlled SOP binders, appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies.
• Escalate to the team lead or Manager any manufacturing performance, process, or safety issues to ensure safety, regulation compliance, and to facilitate continuous process improvement.
• Adherence to GMP training schedule and responsible for achieving all training requirements within acceptable timelines.
• Perform routine housekeeping of the manufacturing plant using the appropriate equipment safety signage, labeling of in-process parts & equipment, squeegeeing liquids to the floor drains, and picking up parts that have fallen on the floor.
• Performs unit operations described in standard operating procedures and batch records.
• Recognize and proactively correct errors in bioprocess operations prior to failure.
• Recommend and execute projects and changes to bioprocess operations to reduce risk and increase efficiency.
• Complete required processing documentation, including product change over and other documentation.
• Review and sign executed process and solution MBRs.

Experience:

• 1+ years of experience in a biotech manufacturing environment or other regulated cGMP manufacturing facility and a Bachelor’s degree in science related area or engineering or Associate’s degree in science related area or Biotech certificate or in lieu of Education requirements 3 years of experience in cGMP manufacturing environment.
• Competency with process equipment and automated control systems.
• Working experience with GMP manufacturing regulations.
• Working knowledge of manufacturing equipment and technology.
• Knowledge of biotech manufacturing process and equipment including cell culture, depth and tangential flow filtration, column chromatography, protein purification and formulation.
• Experience in trouble shooting activities and repairs to production equipment under the guidance of more experienced technicians.
• Ability to understand, apply, and evaluate basic chemistry, biology, and scientific principles as appropriate for the position.
• Proficiency in computer skills, including work with spreadsheet programs (Excel) and word processing (Word).
• Detail orientation with the ability to complete written and verbally assigned tasks following specific instructions and procedures.
• Night shift position

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Responsibilities:

• Excellent employment opportunity for a SAS Programmer to work remotely.
• Act as the strategic computer programming leader to provide support for all aspects of the clinical development process including, but not limited to, clinical development plans, regulatory submissions, programming and information deliverables, commercialization and scientific utilization data for company products.
• Lead the provision of technical consulting expertise to external partners in relation to the specification and delivery of the SDTM and RDB databases by these partners.
• Oversee the quality of all deliverables, holding partners and providers accountable for the quality of their deliverable.
• Lead programming support to the regulatory submissions including specification and delivery of overview data bases, output and response to regulatory questions.
• Identify opportunities to improve the methodology and provide practical solutions for problems.
• Contribute to the development of best practice to improve quality, efficiency and effectiveness.

Experience:

• BSc in Mathematical, Statistical, Computer Science or Life Science
• Extensive SAS programming expertise to an advanced level
• Comprehensive knowledge of technical and regulatory requirements related to the role
• Knowledge of CDSIC standards and industry best practices
• Extensive experience in clinical drug development or healthcare
• Experience in Regulatory submissions
• Excellent verbal and written communication skills and influence stakeholders
• Lead the development and delivery of training
• Able to leverage experience to innovate and streamline workflows
• Knowledgeable of the drug indications within a therapeutic area, their analysis trends, and their effects on data submission standards.
• Able to effectively assess and mitigate risk within a protocol or drug project and proactively determine the need and/or level of escalation
• Leadership role able to lead and direct project work

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Responsibilities:

• Excellent employment opportunity for a QC Associate I/II/III - Bioassay/ELISA in the Fremont, CA area.
• Under supervision, performs testing, conducts lab investigations, problem-solves, and reports aberrant results to management.
• Adheres to GMP good documentation practices
• Performs immunoassays, and cell-based assays
• Work with mammalian cell culture
• Maintain laboratory equipment
• Ensure testing and release time lines are met.
• Follow well-defined and established procedures and best practices.
• Review QC test results
• Generate, review and/or maintain records or documents in a detailed and consistent manner.
• Assist with QC's data management, including data review and control charting.
• Coordinate and manage continuous improvement projects
• Revise standard operating procedures, training manuals, etc. which are submitted to management for review and final approval.
• Maintains specific QC files and database records for process and/or quality improvement efforts.

Experience:

• QC Associate I – Bachelor degree with 0-2 years GMP experience, Associate degree with 2 years GMP experience, High School with 4 years GMP experience
• QC Associate II –Bachelor degree with 2-4 years GMP experience, Associate degree with 4 years GMP experience, High School with 6 years GMP experience
• QC Associate III - Bachelor degree with 4-6 years GMP experience, Associate degree with 8 years GMP experience, High School with 10 years GMP experience
• Demonstrates strong interpersonal and communication skills (both written and oral), a strong customer focus, and an ability to interact with various departments and levels.
• Demonstrates good facilitation, organizational and problem-solving skills, as well as demonstrated.
• Preferred experience performing Bioassay, ELISA, and mammalian cell culture

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Responsibilities:

• Excellent employment opportunity for a Pharmaceutical Manufacturing Associate – Visual Inspection in the Fremont, CA area.
• Perform manual visual inspection of sterile injectable drug products
• Assist in secondary packaging operations
• Responsible for performing filling operations and assisting in visual inspection operations.
• Assist in the setup of filling room and Isolator
• Movement of product, components and equipment within the drug product processing areas
• Transfers product, components and equipment within the CNC, Class C and Class D processing areas.
• Assists with the cleaning of parts and equipment
• Assists with minor equipment repairs/adjustments
• Assists in the identification & correction of problems to prevent down-time
• Communication and hand-off to relief personnel during shift change as appropriate
• Performs manual visual inspection of sterile injectable drug products.
• Assists in secondary packaging operations
• Assists the Sr. Associate and / or Master Associate with Isolator and equipment set up.
• This assistance includes tasks such as gathering tools, machine parts, and documents required for such activities. Retrieves components and equipment from aseptic storage.
• Assists the Sr. and Master Associate with real-time identification and correction of problems.
• Problems may include, but are not limited to mechanical issues, component issues.
• Performs all work in accordance with Company Policies and Procedures.
• All work is documented in controlled documents (batch records, logbooks or SOP attachments) in accordance with SOP.
• All activities are to be documented in the batch record. All events are to be recorded in the batch record and brought to the attention of the production supervisor for further action.
• Assist with Isolator and room cleaning in production areas. Will transfer rubbish to the transfer zones and may empty transfer zones of rubbish when required. This includes removal of equipment, room sanitization and disposal of waste according to established safety requirements.
• Responsible for following controlled documents to ensure that the equipment identified for operation are used and documented. This includes verification of equipment calibration. Completes log books, as required.

Experience:

• Bachelor's Degree, preferably in a science or engineering field.
• Will consider a minimum of an Associate’s Degree with 2 year closely related experience in a GMP or clean room environment OR
• A high school diploma with 4 years closely related experience in a GMP or clean room environment
• Demonstrated mathematical skills, including the ability to perform addition, subtraction, multiplication, division, and conversions.
• Demonstrated ability to read, comprehend, and follow written instructions.
• Demonstrated written and verbal communication skills are required.
• Experiences in related GMP environment within biotechnology/pharmaceutical industry strongly preferred
• Must be able to learn and perform basic computer operations such as MS Office and Outlook and other computer-based software
• Requires physical activity such as almost constant standing, walking, eyestrain, working with hands inside an Isolator, etc. Works regularly under desirable conditions with some moderately disagreeable conditions in the manufacturing setting.
• Position requires acute vision and focus in a demanding visual inspection operation. Position also requires constant use of computer terminals and routine / repetitive work.
• Must adhere to all SOPs, company Policies and Procedures

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Responsibilities:

• Excellent employment opportunity for a Bioengineering Scientist in the Waltham, MA area.
• In this role, you will have the opportunity to explore the dynamics of cells by engineering cutting edge microfluidic platforms to explore signaling dynamics of cellular pathways.
• Your work will develop and engineer novel tools in company labs to understand how these signal dynamics impact tissue and disease-related biology.
• Close connections with projects will allow the proposed translational research to contribute towards increasing the effectiveness of pharmaceutical therapies.
• Quantify impact of drug dynamics on cellular fate in disease and normal tissue models.
• Develop novel in vitro experimental platform for investigating dynamic stimuli in biological systems.
• Develop mathematical models describing systems level behavior of biological pathways.
• Work collaboratively with other experts internally and externally across various disciplines to achieve project initiatives.
• Externally present results at scientific conferences and publish scientific papers in high quality peer-reviewed journals.

Experience:

• To be considered for this Bioengineering Scientist job opportunity you must have a PhD in relevant discipline, such as Biological Engineering, Systems Biology, Engineering or Physics.
• Expertise with standard molecular biology techniques, including mammalian cell culturing
• Experience with quantitative approaches to modeling and analyzing biological data
• Programming or scripting experience
• Experience with microfluidics
• Hands on experience using, designing and building microphysiological or “organ-on-a-chip” systems desired
• Experience with stem cells and/or organoid systems
• Previous experience studying biological signaling networks
• Experience with model building software (e.g. Matlab, Berkeley Madonna, R)
• Knowledge of cancer biology including DNA damage response and apoptosis pathways

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Responsibilities:

• Excellent employment opportunity for a Regulatory Affairs in the Raritan, NJ area.
• Develop regulatory deliverable timeline and schedule for each assigned Project VANTAGE project.
• Review and approve Change Projects, Change Orders, and project documentation, according to ADAPTIV approval metrics.
• Complete Preliminary and Final Regulatory Assessments and regulatory strategies, according to ADAPTIV approval metrics.
• Participate in design control activities.
• Provide ADAPTIV support to backroom for BSI Technical File audits and FDA audits
• Prepare and submit product, manufacturing, packaging, or labeling/IFU changes to European Notified Body, as required through Significant Change Supplements or Notifications.
• Prepare 510(k)’s to FDA pertaining to device changes requiring FDA clearance, as required and as determined by regulatory strategy.
• Submit notifications to company Regulatory Affiliates pertaining to changes to product, manufacturing, packaging, labeling, etc.
• Provide necessary documentation to country affiliates, where needed.
• Daily communication and meeting attendance with Project VANTAGE project teams.
• Daily or weekly communication with Regulatory Management subsidiary on Project VANTAGE project status and deliverables.

Experience:

• To be considered for this Regulatory Affairs job opportunity you must have a Bachelor of Science degree.
• Must have experience in the medical device or related industry.
• Must have experience in Regulatory Affairs.
• Must be able to work independently, utilizing research and problem-solving skills, and the willingness to learn new skills.
• Must have excellent written, verbal communication and presentation skills.
• Must have solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive.
• Must be able to work in a timeline-driven environment.
• Must have previous experience with document management systems and change control systems.
• Project team experience is a plus.Experience to manage a complex project is a plus.

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Responsibilities:

• Excellent employment opportunity for a QC Associate in the Fremont, CA area.
• Execute and coordinate routine and non-routine testing in QC of bulk drug substance and drug product in a multi-product facility.
• Execute independently with adequate training fundamental operations such as biochemistry, drug product device testing, UV-vis absorbance, gel electrophoresis, pH, Osmolalilty.
• Perform internal support duties including stocking consumables/materials, updating controlled SOP binders, appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies. Delivery of high-quality analytical results within timeline right the first time.
• Document work according to cGMP and cGDP. Adhere to established regulations and follows cGMP established by site. Report abnormalities and deviations in a timely and accurate manner.
• Adhere to safety standards and identifies unsafe situations / habits and escalates appropriately. Maintains work production areas according to predefined standards (5s).
• Maintain own training within compliance and trains other technicians and associates on operations upon completion of trainer qualification.
• Represent QC operations on cross-functional root cause analysis teams for deviations, CAPAs and risk assessments.

Experience:

• Bachelors' Degree in Biology or Life Sciences required.
• Must have 3-5 years of industry experience.
• GMP experience is highly preferred.
• Demonstrates strong interpersonal and communication skills (both written and oral).
• Ability to work independently and as part of a team.
• Demonstrates strong attention to detail.

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Responsibilities:

• Excellent employment opportunity for a Specialist, Quality Systems in the Fremont, CA area.
• Support in the implementation and maintenance of our Inspection Readiness Program.
• Support process improvement initiatives for inspection readiness program, inspection logistics and inspection process.
• Conduct trainings for inspection support role.

Experience:

• Bachelor's Degree in Microbiology, Biology, Chemistry (Or closely related degree with these core courses as the foundation) with 5-8 years of relevant experience.
• Preferred experience in project management. Must have ability to lead routine tasks related to inspection readiness program, inspection logistics and inspection process
• Attention to detail, good organizational skills, interpersonal skills, and problem-solving skills.
• Ability to prioritize and work under pressure. Ability to work effectively and to respond quickly in a fast-paced environment.
• Knowledge of Quality Systems, specifically Inspection Readiness, Data Integrity, CAPAs, and Deviations. Working experience in either Quality Systems, QC, and QA Role.

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Responsibilities:

• Excellent employment opportunity for a Scientist II in the Ridgefield, CT area.
• As a biomarker scientist, you will work with animal and human samples to identify, develop and validate novel biomarkers of kidney pathology and therapy.
• The biomarker assays will involve work with protein, RNA, and exosomes from tissue, urine, blood and require extensive knowledge, good lab skills and strong data analysis capability.
• Identify, develop, and validate novel biomarkers based on project needs.
• Develop and establish new biomarker assays.
• Perform general biomarkers assays and analyze the data.
• Clearly communicate timelines and study results within the group and with project teams.
• Independently and /or collaboratively performs scientific experiments (in vitro, in vivo and ex vivo) with a predefined goal including developing new methodologies, protocols and/or testing procedures that contribute to project /research goals.

Experience:

• To be considered for this Scientist II job opportunity a Bachelor’s Degree in relevant scientific discipline (e.g. cell biology, molecular biology, biochemistry, etc.); Master’s degree is highly preferred.
• Minimum of 1 year bench work experience.
• The successful candidate will be a self-motivated, accountable bench scientist with the ability to apply his/her skills to meet diverse project needs in a fast-paced dynamic team environment.
• Experience with biomarker assay technologies including antibody-based detection methods (e.g. ELISA) and multiplexed detection methods (e.g. Luminex, MSD) is desired.
• Hands-on experience in the development and validation of biomarker assays in the preclinical and clinical setting is desired.
• A proven track record of research accountability and productivity within a team setting is highly desired.
• Experience working in a lab to perform routine lab experiments (Cell culture, sample preparation, ELISA, Western blot, qRTPCR, etc.)
• Trouble-shooting skills during assay development and optimization
• Strong communication skills.

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Responsibilities:

• Excellent employment opportunity for a Statistician in the Gaithersburg, MD area.
• To lead the strategic, statistical thinking and contributions to the Development Plans, Regulatory Strategy, Health Technology Assessment and Commercial Presentation for indications/projects within a company product team.
• Leadership to statistical staff on the indications/projects so that all work is carried out with regards to company standards and external regulations
• Through partnership with experts, developing design options and providing high quality decision support to enable the business to make informed decisions
• Quantifying the benefit, risk, value and uncertainty of the emerging product profile.
•  Holding CRO/Partners accountable for the high-quality standards of their deliverables
• Represent company and Statistics to Health Authorities and Reimbursement/Payer Organizations for specific projects/indications;
• Application of expert skills to investigate, apply novel statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration.
• Mentor/coach and support the education and training of Statistics staff in the technical arena.

Experience:

• MSc/PhD in Statistics or Mathematics (containing a substantial statistical component) with experience in pharma/healthcare or other relevant area
• Leadership Capabilities
• Knowledge of the technical and regulatory requirements related to the role
• Experience of Development, programme design and data analysis and interpretation
• Experience of regulatory interactions and/or submissions
• Excellent communication skills and ability to build strong relationships
• Leadership role able to lead and direct elements of project work
• Accountable for the statistical work within the project
• Report to Senior Statistical Science Director

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Responsibilities:

• Excellent employment opportunity for a Regulatory Affairs in the Somerville, NJ area.
• Develop regulatory deliverable timeline and schedule for each assigned Project VANTAGE project.
• Review and approve Change Projects, Change Orders, and project documentation, according to ADAPTIV approval metrics.
• Complete Preliminary and Final Regulatory Assessments and regulatory strategies, according to ADAPTIV approval metrics.
• Participate in design control activities.
• Provide ADAPTIV support to backroom for BSI Technical File audits and FDA audits
• Prepare and submit product, manufacturing, packaging, or labeling/IFU changes to European Notified Body, as required through Significant Change Supplements or Notifications.
• Prepare 510(k)’s to FDA pertaining to device changes requiring FDA clearance, as required and as determined by regulatory strategy.
• Submit notifications to company Regulatory Affiliates pertaining to changes to product, manufacturing, packaging, labeling, etc.
• Provide necessary documentation to country affiliates, where needed.
• Daily communication and meeting attendance with Project VANTAGE project teams.
• Daily or weekly communication with Regulatory Management subsidiary on Project VANTAGE project status and deliverables.

Experience:

• To be considered for this Regulatory Affairs job opportunity you must have a Bachelor of Science degree.
• Must have experience in the medical device or related industry.
• Must have experience in Regulatory Affairs.
• Must be able to work independently, utilizing research and problem-solving skills, and the willingness to learn new skills.
• Must have excellent written, verbal communication and presentation skills.
• Must have solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive.
• Must be able to work in a timeline-driven environment.
• Must have previous experience with document management systems and change control systems.
• Project team experience is a plus.
• Experience to manage a complex project is a plus.

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Responsibilities:

• Excellent employment opportunity for a QC Microbiology Associate in the Fremont, CA area.
• Day to day duties will include but not limited to: Perform WFI sampling, perform Bioburden testing of in-process samples, raw materials, equipment rinses, WFI and bulk drug substance using Membrane Filtration method, and Pour plate method.
• Perform LAL (Endotoxin) testing using Kinetic Turbidimetric and Kinteric Chromogenic method.
• Perform microbial identification on Environmental Monitoring samples In Process Testing samples, and for other groups. Perform growth promotion testing of microbiological media.
• Assist in the preparation of periodic trend reports and analysis of microbiological data.
• Assist in laboratory investigations of microbiology excursions.
• Enter data in QC LIMS or other databases in a timely manner. Perform other miscellaneous Lab maintenance activities.
• Should be able to lift, carry, push or pull up to 50 pounds occasionally.
• Assist in revising Standard Operating Procedures, as needed.
• Perform document reviews as required. Ensures sampling, testing and release timelines are met. Follows well-defined and established procedures and best practices.

Experience:

• BS Degree in Science (Preferably in Microbiology or other relevant fields).
• Demonstrates proficient computer skills (i.e. documentation systems, databases and spreadsheets), knowledge of Microsoft applications, must be able to use computers to perform data-entry functions etc.
• Must have experience with GMP and GDP.
• Demonstrates excellent interpersonal and communication skills (both written and oral).
• Demonstrates ability to work under minimal direction and as part of a team.
• Demonstrates good facilitation, organizational and problem-solving skills.
• Must have experience with Pipetting.
• Should be able to demonstrate excellent pipetting skills.
• Must have working knowledge of relevant Standard Operating Procedures, U.S. and E.U. Good
• Manufacturing Procedures and other regulatory requirements.
• Must be able to work flexible hours.

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Responsibilities:

• Excellent employment opportunity for a Sr. DMS Coordinator in the Fremont, CA area.
• Under general supervision, performs routine administrative tasks to support the creation, revision, and retirement of controlled documents according to Standard Operating Procedures, to support current Good Manufacturing Practices operations.
• Incumbent also supports the management and audit of vital records, and electronic records stored at the facility. Assignments/tasks require action and initiative to resolve problems and develop recommendations.
• Manages controlled documents for the Fremont site, to ensure correct implementation, access, and upkeep of documents.
• Acts as key point of contact for author and record users and provides customer support and simple troubleshooting for creation and editing of documents.
• Distribute document links to the appropriate viewers. Informs users on the best ways to use the system; directs users to additional help, training courses and e-learning.
• Provide local business administrators with information about the appropriate roles for document signatories.

Experience:

• Bachelor’s Degree and/or Professional Training
• 2-5 years of experience, excellent communication skills, both verbal and written.
• Competence in EDMS software and MS Office suite - particularly Outlook and Word; familiar with use of styles, formatting tools, transferring content from document to document.
• Demonstrates the ability to clearly and concisely present/explain documentation systems and requirement guidelines to other staff.
• Experience with document version control.

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Responsibilities:

• Excellent employment opportunity for a Validation Engineer in the Durham, NC area.
• Will be responsible for overseeing the development of a new analytical robot for inhaler testing.
• Project Management, People Management, Problem Solving, Communication
• Act as the cross-site Lead for the creation of the User Requirement Specification (URS).
• Arrange and lead workshops to accurately map, and where possible, simplify business workflows and translate them into unambiguous user requirements.
• Organize requirements in an optimal way, aspiring to create a state of the art URS i.e. covers all aspects of the future robot in a human friendly way.
• Liaise with all supporting functions whose input is required for the creation of the URS e.g. Quality Assurance, IT and SHE.
• Secure that all work is performed according to the Quality Management Framework and cGMP standards.
• Liaise with vendor to ensure design aligns with the URS.
• Manage SAT, FAT, PQ and IQ/OQ activities and documentation.
• Support the Business in reviewing URS responses from potential suppliers of the robot.
• Support the Project Manager with updating schedules, costs, and risks as needed.

Experience:

• Degree in a relevant science or engineering discipline
• Minimum 5 years of experience of leading work around development of URS documents related to automation set within a GxP regulated environment.
• Previous experience around automating analysis of inhalers is desirable.
• Knowledge of GAMP5 Requirements is desirable.
• Collaborative
• Proven communication and organizational skills for global working
• Able to travel up to 50% time.
• Candidate must be open to travel to Sweden and France. Travel is non-negotiable.
• Analytical Automation experience is preferred as well.

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Responsibilities:

•  Excellent employment opportunity for a Research Associate in the Durham, NC area.
• Support Pearl MDI product development from product definition stages to product approval and launch by devising and conducting analytical experiments.
• Under general guidance, design experiments and conduct analytical experimental work related to advancing Pearl product quality and performance.
• Able to identify aberrant data and effectively communicate observations to project management.
• Participate in the development of an investigational plan.
• Under general guidance, begins to develop project leadership skills.
• Effectively document experiments and results in appropriate formats.
• Under general guidance, prepare technical reports and/or CoAs to summarize data and document experimental conclusions.
• Under general guidance, evaluate data for trends indicative of product performance, method performance, or analyst performance.
• Mentor junior staff members on analytical technique, technical writing, or development of technical judgment.
• Communicate project status and concerns to management.

Experience:

• MS with 0+ years, BS with 3+ years of pharmaceutical industry experience.
• 3+ years of experience testing inhalation products preferred, especially MDIs, with a variety of active pharmaceutical ingredients at different stages of development.
• University degree (BS or MS) in the field of chemistry, pharmaceutical science, or related field.
• In-depth knowledge in at least one relevant field: HPLC, GC, KF moisture testing, MDI performance testing.
• Familiarity with relevant ICH, USP, EP, and FDA guidance documents as well as cGXPs in support of MDI product testing.
• Must be able to effectively communicate verbally and through technical writing (documentation of laboratory experiments).
• Must be able to operate a PC and sit for extended periods of time. Some lifting required (not more than 50 lbs.).
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Must be willing to shave facial hair for respirator use as part of lab responsibilities as needed.

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Responsibilities:

• Excellent employment opportunity for a QC Associate III- Raw Materials in the Fremont, CA area.
• Performs sampling/testing/inspection of raw materials, conducts lab investigations, problem-solves, and reports aberrant results to management.
• Pulling and aliquoting raw material samples and distributing to the appropriate laboratories
• AQL inspection (e.g., visual defects, dimension testing, and all required attributes
• Ships samples to appropriate testing laboratories and prepares paperwork for testing.
• On call coverage for urgent samples.
• Ensures sample integrity is intact, paperwork complete and correct and LIMS entries are performed.
• Follows well-defined and established procedures and best practices.
• Reviews QC test results
• Generates, reviews and/or maintains records or documents in a detailed and consistent manner (e.g., sample summary form, test records, retain sample forms, etc.).
• Prepares sample reconciliation reports and other reports as needed.
• Assists with QC's data management, including data review and trending.
• Performs logbook and/or LIMS entries when using equipment/instruments. Reconciles samples.
• Perform weekly and monthly reviews of appropriate forms (e.g., test records) and logbooks.
• Performs an Owner role for Change Controls and Deviations
• Independently writes and/or updates raw material specifications and reports.
• Responsible for ensuring all raw material documentation and reports are reviewed and are in accordance with the raw material specifications.
• Generates, reviews and/or maintains records or documents in a detailed and consistent manner.
• Prepares sample reconciliation reports, periodic trend reports, generate metrics and other reports as needed.
• Reviews and reconciles reports with internally produced data. Maintains raw material released data lot packets and reports, creates raw material final reports.
• Revises standard operating procedures, training manuals, etc. which are submitted to management for review and final approval.
• Ensures equipment calibration and preventive maintenance are up-to-date
• Maintains specific QC files and database records for process and/or quality improvement efforts.
• Works with SQM and Quality Compliance on material qualification.

Experience:

• Bachelor's Degree in a Scientific Discipline.
• In depth experience in a laboratory environment with direct experience in bio-analytical techniques and equipment related to the testing of biotechnological products or chemicals
• Six (6) years cGMP or appropriate experience required.
• Knowledge of ANSI/ASQ Z1.4, DIN ISO 2859 or other sampling standards required.
• Strong technical writing required
• Knowledge of CFR, USP, and ICH required.
• Knowledge of SAP, Trackwise and LIMS desired.
• Working knowledge of Microsoft Office systems, LIMS, lab instrumentation and other relevant systems
• Lifting, carrying, pushing or pulling up to 50 pounds occasionally
• Frequent periods of sitting, walking, and standing
• Occasionally must climb stairs or ladders, balance, bend or stoop, crouch or squat
• Occasional low -level work, fine finger dexterity/ including grasping or pinching required
• Must be able to read electronic documents of all types.
• Hearing acuity required.

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Responsibilities:

• Excellent employment opportunity for a Drug Safety Associate-I in the Horsham, PA area.
• Responsible for the receipt and data entry of adverse event reports following company standard operating procedures, internal business practices and regulatory guidance.

Experience:

• To be considered for a Drug Safety Associate-I job opportunity a Health/Biomedical Degree (BS, PhD or other related scientific degree/qualification) OR
• Licensed Practical Nurse without Bachelors degree but with knowledge of Drug Safety usually exhibited by minimum 5 years of experience in pharmaceutical safety-related role.
• Registered Nurse OR Pharmaceutical industry experience is preferred
• Intermediate Information Technology Skills
• Proactive approach/uses own initiative
• Manages own work, able to prioritize, plan and organize work assignments and work under strict timelines
• Ability to follow guidelines, working practices etc. Experience of working with SOP/WI preferred
• Quality oriented, with attention to detail/accuracy
• Good written and verbal communication skills
• Understanding of medical terminology

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Fladger & Assoc. Inc. is seeking 1 professional for Fulltime employment (40 hours a week) for the position of Drug Safety Specialist at Bear, DE 19701 at competitive salary. Posted 10/11/16

Responsibilities:

• Responsible for processing individual case safety reports according to SOPs and local/international regulations.
• Perform triage for all incoming.
• Participate in the case review process to ensure accurate medical safety data documentation.
• Perform all data entry and other required administrative functions in the safety database.
• Ensure accurate and consistent coding of diseases, adverse events, and medications according to the project-specific coding conventions in the Safety Database.
• Assist team in the preparation of regulatory safety reports; Assist in the SAE reconciliation.
• Travel within USA required.

Experience:

• To be considered for this Drug Safety Specialist job opportunity you must have a Master’s in Business Admin with Pharmaceutical Management Major plus 2 years of Experience in any related field.

We offer comprehensive benefits.

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