- Novo Nordisk Inc. (Durham, NC)
- …QC - OFP. Essential Functions Accuracy & Scientific Soundness of Lab Data Environmental Compliance GMP Compliance of Laboratory Maintain testing proficiency ... help us make what matters. The Position Perform & review analysis of in-process, release & stability samples in...preferred Able to perform routine testing per SOP & GMP standards preferred Knowledgeable in basic laboratory techniques preferred… more
- Merck & Co. (Millsboro, DE)
- …training and oversight of the animal care staff, serving as a designated reviewer and voting member of the Institutional Animal Care and Use Committee (IACUC), ... and maintenance of animal facilities. This position is responsible for providing data , documentation, and other information as needed for annual reports to Federal… more
- BioAgilytix (Durham, NC)
- …on assay development projectsServe as lead scientist on validationPresent data to clientsIndependently write plans and reports for validationResponsible for ... prompt identification and notification of deviationsPerform assays according to GMP guidelinesFollow GMP guidelines for validation of assaysDevelop and run… more
- Merck & Co. (Rahway, NJ)
- …regulatory filings.Design, plan, and execute laboratory experiments to generate high quality data .- Perform data analysis and ensure results are reported clearly ... with research and commercial teams to deliver process documentation packages, review batch records, support technology transfer activities, and provide investigation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Oncology Medical Affairs LT, Specialty MA LT, Development (as applicable), GMP QA, and engagement with external partners as deemed necessary.This position is ... QA, CSPV and other internal QA stakeholders such as GMP QA, specifically for specialty pharmacy, REMS, co-partners and...that audit targets for MA audits are in place. Review risk assessment documents stemming from audit outcome to… more
- Merck & Co. (Rahway, NJ)
- …Biomedical Engineering, Bioprocessing, Business, Cell Cultures, Communication, Cryopreservation, Data Analysis, Decision Making, Detail-Oriented, GMP Compliance, ... filing activities to ensure a smooth and clear path to successful GMP operations and BLA filings for the company's pipeline.Leads and/or supports program-specific… more
- Merck & Co. (Rahway, NJ)
- …Management, Clinical Testing, Clinical Trial Management, Cross-Functional Team Leadership, Data Analysis, Detail-Oriented, Good Manufacturing Practices ( GMP ), ... chain deliverables and prepares, analyses, and/or develops mitigation strategies for review with clinical partners and senior leaders.--Works directly in the SAP… more
- Merck & Co. (Rahway, NJ)
- …deliverables and prepares, analyzes, and/or develops mitigation strategies for review with clinical partners and senior leaders.--Responsible and accountable for ... technical & business risks, & influence portfolio decisions with facts and data -Demonstrates ability to balance strategy with ability for tactical execution and… more
- Merck & Co. (Durham, NC)
- …start-up and commissioning and qualification through licensure and ramp up-Author, review , and/or edit procedures and technical documents to support regulatory ... role-ORBachelor's degree and two (2) years of experience in a direct GMP , biotechnology, and manufacturing setting.Experience and Skills Required Willingness to work… more
- Eisai, Inc (Exton, PA)
- …Production Qualifications (PQ) and IT regulation (eg 21 CFR Part 11, Data Integrity) compliance as assigned.Collaborates with project teams to create, update and ... internal and external computing platforms and solutions.Conducts audits and periodic review as assigned for quality assurance compliance with regulations and Eisai… more
