- Merck & Co. (Durham, NC)
- …drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection , and quality control laboratories. - The Quality ... Job DescriptionPosition Description: Specialist, Quality Assurance 2nd Shift - Our Company constructed...The focus for the position includes all aspects of Quality oversight for drug product, drug substance, media preparation,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …applicable areas Provide QA oversight to pharmaceutical Operations and perform acceptance quality limit (AQL) inspection Perform Quality Assurance compliance ... direct support for all finishing manufacturing activities. This position supports the Quality Systems within the Quality Assurance Unit ensuring compliance with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and information needed to ensure oversight of ongoing review of risks by evaluating Quality Events (QEs), audit, and inspection outcomes so these data may be ... immune disorders. SUMMARYProvide support to the Global and Regional Quality Leads, External Partner Quality Leads, and...the Global RD/PV QA team. May be assigned other Inspection Management Team (IMT) roles in support of … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …focused on an EHS first mindset, a Right First Time culture of quality , permanent inspection readiness compliance mindset and passionately drives continuous ... programsAssists in the creation, tracking and completion of metrology related SOPs, quality events, CAPAs, Out of Tolerance (OOT) situations and other technical… more
- Merck & Co. (Durham, NC)
- …work at the shop floor level. Collaborates with Operations, Technology and Quality to author regulatory inspection observation responses and completes ... record review within established timelines for release and effectively liaisons with Quality to resolve comments in a timely manner. Day shift Operations… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study budget is reconciled with Finance on an ongoing basis.Support all inspection readiness and quality initiatives pertaining to assigned stud(ies).Ensures ... Leadership:Has primary accountability for operational study level time, cost and quality deliverables.Lead the development of the clinical study plan including… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of six (6) years of experience in Quality Assurance/ Quality Systems or ComplianceExperience conducting internal audits (self- inspection ), including writing ... promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Manager as part of the Quality team based in… more
- Merck & Co. (Durham, NC)
- Job DescriptionJob Description:Senior Specialist, Quality AssuranceThe Senior Specialist, Quality serves as a member of a team responsible for instituting ... Complaints, Corrective Action/Preventive Action Management, Annual Product Review Authoring, and Quality Council.The Senior Specialist, Quality Assurance will be… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of identified access discrepancies per study to maintain overall compliance and inspection readiness of the application. This position will establish and maintain ... and maintaining new SOPs, Work instructions, templates, and other quality documents.Responsibilities:Leadership, Direction, and Strategy: Establish and manage accountability… more
- Merck & Co. (Durham, NC)
- …make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant ... connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products. The HVAC & R Senior Technician… more
