- Merck & Co. (North Wales, PA)
- …Reporting to Senior Management of the Medical Device and Combination Product (MDCP) Quality Assurance Operations team, the Associate Director Quality ... and other worldwide regulations and our Compa requirements.This position provides Device quality engineering and quality assurance support and leadership… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …compliance with specifications and procedures Releases product based on Quality Assurance record review and approval by QA Manager Performs regular internal ... audits of NNUSBPI facilities as a lead auditor Works closely with Manufacturing and ...leading international regulatory agency preferred As applicable, experience with Quality Assurance oversight and support for all… more
- Catalent (Philadelphia, PA)
- Quality Assurance Document Control Supervisor Position Summary Catalent Pharma Solutions in Philadelphia, PA is hiring a Quality Assurance Document ... committed to a Patient First culture through excellence in quality and compliance, and to the safety of every...SOPs related to batch record documentation and release.Act as lead investigator for all Problem Reports regarding batch record… more
- Insmed Incorporated (Bridgewater, NJ)
- …knowledge of cGMPs and pharmaceutical manufacturing, Quality Control and Quality Assurance .Commercial drug manufacturing site QA head experience ... follow relevant regulatory GMPs and global company policies & proceduresLead overall management of Quality Assurance programs to support the QC lab and to ensure… more
- Catalent (San Diego, CA)
- Job Title: Quality Assurance Associate, Analytical City: San Diego State : CA JOB DESCRIPTION:Review of analytical release and stability data, involving review ... and manufacturing equipment.Point person for safety complaints and improvements in the Quality Assurance Department using the Intelex software for logging… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … team based in Raritan, NJ. Role Overview The QA Investigations Lead has the responsibilities for providing quality oversight over the production of ... treatment of multiple myeloma. Legend Biotech is seeking a QA Investigations Lead (2nd or 3rd shift)...experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the candidate hasexperience working in an aseptic manufacturing facility, preferably in quality assurance ,manufacturing compliance, clinical quality , or cell ... QA Shop Floor Supervisor as part of the Quality team based in Raritan, NJ. Role Overview The...supervising employees is preferred. Ability to work with and lead others in a team environment. Demonstrated ability to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Supervise a team of QA Investigations Leads. Provide guidance to the Quality Leaders about handling the various nonconformances. Lead the daily touch point ... must have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …PV QA strategy in close collaboration with the VP, Global head of Quality Assurance (RD/PV QA ). CAPAs Ensure adequate CAPAs are defined, implemented, ... the lead as the Head of PV QA with Quality Reviews of respective product... reports QQRs and or assigned by VP Global Quality Assurance (RD/PVQA) delivered in a timely… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works closely with Quality ... Trial Master Files (TMF) with CSO-related documentsSupports the CSO Project Mgmt Lead in executing additional operational and logistical duties as discussed and… more
- Merck & Co. (Rahway, NJ)
- …business effectiveness. This will include ongoing partnership with the Research & Development Division Quality Assurance ( QA ) and acting as the link between ... data from clinical trials conducted worldwide. In partnership with the Clinical Quality Operations Lead (CQOL) and Head of Clinical Quality Operations, the… more
- Tris Pharma (Monmouth Junction, NJ)
- …Summary:The Manager, Quality Management Systems (QMS) supports, oversees and manages the Quality Assurance ( QA ) Investigations and Product Quality ... Improvements (CPIs)Works directly and cross functionally throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Lead role as part of the Quality Operations team based in… more
- Merck & Co. (Rahway, NJ)
- …support investigations and provide expert opinions or technical assistance as needed. Quality Assurance and Compliance:-Develop and implement protocols and ... workload, and ensure the lab maintains a high standard of quality and accuracy.Digital Forensics Investigations:-Conduct and oversee complex digital forensic… more
- Merck & Co. (North Wales, PA)
- …Strong listening skills.Demonstrated sound understanding of related fields (eg, manufacturing, analytical, quality assurance ) and the ability to be creative and ... sections for commercial or new biologics products. The Principal Scientist will lead the development and the implementation of internal regulatory strategies and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …support, including Service delivery and Incident response) IT Infrastructure SME for Quality assurance / GMP and Validation: Maintain qualified state of ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...other local SMEs in IT/OT, System Managers, and IT QA Maintain IT services and operations according to service… more
- Eisai, Inc (NJ)
- …provider business relationships in alignment with global strategies.Review and approve Clinical Quality Assurance audit plans and reports.Review and respond to ... from you. Job Summary The Associate Director, Clinical Outsourcing, will oversee and lead and support activities related to the outsourcing of clinical services to… more
- Insmed Incorporated (Bridgewater, NJ)
- …substance sections of regulatory filings and dossiers.Sound awareness of Regulatory, Quality Assurance , and cGMP requirementsHigh energy, innovative "can do" ... for being the Technical Operations liaison to the Insmed research team for lead optimization and early development programs. This position will be the dynamic… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …with an interdisciplinary team that includes but is not limited to quality assurance , quality control, operations, engineering, maintenance, calibration, ... from various sources across the organization in order to lead and perform Root Cause Analysis to determine the... quality , technical services, subject matter experts, and quality approvers to ensure appropriate and timely determination of… more
- Catalent (San Diego, CA)
- …and compliance.Collaborate with other departments to troubleshoot technical issues.Collaborate with Quality Assurance and Quality Control on analytical ... studies to determine if methods are suitable for transfer to Quality Control.Communicate results both internally and externally through oral and written… more
