- Aequor (Athens, GA)
- … Control Data will manage the following functions in the Quality Control Department: Sample Life Cycle Management in compliance with procedures and ... of retention samples and retention database. Data Integrity: Responsible for Quality Control test record issuance, filing and reconciliation. Accountable… more
- Catalent (Philadelphia, PA)
- …patient and employee safety, will assist in the enforcement of GMPs and regulatory compliance through FDA and Catalent requirements, and will provide customer ... Quality Assurance Document Control Supervisor Position...records, etc; Respond to and investigate customer complaints.Audit for compliance as pertains to Catalent SOPs, regulatory ,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … Quality team based in Raritan, NJ. Role Overview The Quality Compliance - Lead Auditor CAR-T is responsible for regulatory compliance supporting the ... the treatment of multiple myeloma. Legend Biotech is seeking Quality Compliance Lead as part of the...audits; manage audit responses and observation resolution. Drive site compliance to regulatory , enterprise, and global requirements… more
- Catalent (St. Petersburg, FL)
- …manufacturing challenges.Catalent is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, ... Compliance Manager is responsible for providing Leadership and Quality Assurance Management support within Catalent's St. Petersburg site. The Department… more
- Aequor (West Greenwich, RI)
- …as necessary. 6. Perform general laboratory housekeeping activities. 7. Maintain training compliance and proficiency. 8. At all times, comply with safety guidelines, ... cGMPs/CFRs and other applicable regulatory requirements. Shift: Tuesday - Friday shift schedule. Skills: Previous lab experience is preferred.Basic Qualifications:… more
- Eisai, Inc (Nutley, NJ)
- …educating end-users on compliance requirements. Additionally, you manage regulatory compliance activities, maintain accurate documentation, and evaluate new ... crisis management.Manage IT training programs and conduct Segregation of Duties reviews. Regulatory Compliance Activities:Collaborate with legal and compliance… more
- Aequor (Thousand Oaks, CA)
- …PQ staff and executive leadership, International Quality , Quality Control , Contract Manufacturing Quality , Regulatory , Process Development, ... in support of product development? Knowledge of protein and small molecule quality , compliance and regulatory requirements? Knowledge of analytical… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- … Quality Systems specialist will support GMP activities to ensure compliance with regulatory and company requirements. Job Responsibilities:Assist with ... approving CAPAs in Veeva.Write/update SOPs and other documentation pertaining to Quality SystemsPotential participation in health authority, 3rd party, and internal… more
- Merck & Co. (Durham, NC)
- …and safe maintenance and repair of equipment using Hazardous Energy Control Procedures. Compliance with current good manufacturing procedures(cGMP), safety and ... written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs)… more
- Tris Pharma (Monmouth Junction, NJ)
- …(CPIs)Works directly and cross functionally throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior ... Leadership, etc.) on deviations and PQC investigations relating to production operations, quality operations oversight and quality control analysis and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …of NNUSBPI facilities as a lead auditor Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, internal ... or biologic facility regulated by the FDA, EMEA or a leading international regulatory agency preferred As applicable, experience with Quality Assurance oversight… more
- Catalent (Philadelphia, PA)
- …guidance to the Quality Disposition, Materials Sampling Quality Assurance, Regulatory and Compliance Quality Assurance, and Validation Quality ... and effective quality system that delivers reliable, high- quality products that meet all customer and regulatory...have responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, Change Control… more
- Novo Nordisk Inc. (West Lebanon, IN)
- … compliance with specifications and procedures Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, walk ... reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI products. This… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …accuracy of laboratory documentation.Help with the implementation and interpretation of applicable quality and regulatory requirements (eg, FDA, GLP, QSR, cGMP, ... new product support.Operate and troubleshoot procedures for lab equipment, and quality and regulatory requirements important to pharmaceutical and combination… more
- Merck & Co. (Durham, NC)
- …and uses this knowledge in own work.Understands and applies regulatory / compliance requirements.FUNCTIONAL EXPERTISE:Our Digital Manufacturing Operations ... make our products. We work in our manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant… more
- Merck & Co. (Durham, NC)
- …procedures to resolve process/equipment issues, minimize downtime, and ensure product quality .- This role actively supports, participates, and embraces an inclusive ... team culture including significant interaction with Operations, Quality , Automation, Technology, and other groups as required. Primary activities for this position… more
- Merck & Co. (Durham, NC)
- …and safe maintenance and repair of equipment using Hazardous Energy Control Procedures. Compliance with current good manufacturing procedures(cGMP), safety and ... written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs)… more
- Aequor (Bothell, WA)
- …relevant work experience in pharmaceutical quality operations, quality assurance, quality systems, and/or IT compliance role with at least 3&plus years ... AND SCOPE OF POSITION: This position reports into the Quality Assurance department and is responsible for assisting with...e-systems used across the site operations are conducted in compliance with applicable Data Integrity related regulatory … more
- Merck & Co. (Durham, NC)
- …& Component SuppliersAuthor, review, and/or edit validation documents to support regulatory filingsSupport Change Control documentation for complex process, ... 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… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Specialist, Equipment Management is responsible for equipment lifecycle management and Quality Control (QC) systems administration. Key Responsibilities Develop ... seeking QC Specialist, Equipment Management as part of the Quality team based in Raritan, NJ. Role Overview The...and manage records for corrective and preventative actions, ensuring compliance with regulatory standards. Draft, review, and… more
