- 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
- 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 (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
- 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
- Insmed Incorporated (Bridgewater, NJ)
- …support system and/or process enhancements to support business needs and/or regulatory updatesSupport additional compliance initiatives and projectsFoster a ... particular relating to Commercial practices of a US business.Understanding of compliance internal control concepts and framework.Maintains understanding of laws… 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
- Merck & Co. (Durham, NC)
- …for daily support and oversight of all production processes to ensure compliance with regulatory requirements as well as policies and procedures.-Responsible ... Job DescriptionThe Quality Senior Specialist provides expertise in the coordination...participates in project suite teams, as required.Direct support of regulatory inspections and audits.Direct support of validation activities and… 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
- Insmed Incorporated (Bridgewater, NJ)
- …are conducted on assigned complaints to ensure completeness, accuracy, and regulatory compliance , including batch reviews, identify root causes, replacement ... Quality Complaints. The primary responsibilities include managing QA Compliance activities, including technical writing of Deviations/CAPA/EC documents. Monthly/Quarterly… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …requirements Continuously monitor and improve documentation and processes to ensure compliance with regulatory requirements and Novo Nordisk standards. Work ... Quality Systems activities including Document Management system, Change Control , Deviations, and CAPA's Writing and/or revising procedures applicable to CSV… 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
- 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
- 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …and interests from the world's biomedical literature in support of regulatory , clinical research, marketing, and legal functions.- Plans, organizes, monitors, ... Maintains up-to-date awareness in the areas of literature-related copyright compliance , adverse event reporting, and information storage and retrieval systems.-… more
- Merck & Co. (Rahway, NJ)
- … control systems to improve production efficiency and product quality .Collaborate with cross-functional teams, including operations, maintenance, and quality ... for optimizing and maintaining our manufacturing processes using process control systems and automation and operational technologies.Responsibilities:Assist in the… more
- Merck & Co. (Rahway, NJ)
- …development, control strategy, and specifications-setting.-Deep working knowledge of regulatory guidance and quality standards, with experience authoring and ... transfer to GxP laboratories.- He/she will be responsible for managing quality science and effective prioritization to bring analytical representation and expertise… more
