- Accentuate Staffing (Clayton, NC)
- …and verify training effectiveness. Work closely with team members to enhance quality and compliance . Communicate corrective actions from investigations clearly ... of ours in the Clayton area recruit for a Quality Improvement Specialist to join their team. This is...and ensure all team members are informed. Maintain compliance with standardized operating procedures (DFP standards) during shifts.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Lead as part of the Quality team based in ... a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop...Raritan, NJ. Role OverviewThe Quality Compliance - Lead Auditor CAR-T is responsible for regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …brand review, etc.) preferred- 1 or More Years Relevant experience in compliance and/or privacy preferred- Pharmaceutical compliance or healthcare ... IT, Medical Affairs, Sales/Marketing, Managed Markets, Pharmacovigilance, Supply Chain, Compliance , Quality Assurance, pharma-specific litigation issues, promotional… more
- BioAgilytix (Durham, NC)
- …you enable life-changing, life-saving therapeutics to the patients who need them.The Quality Engineer is responsible for assisting in providing quality oversight ... 21 CFR Part 11, Annex 11, Annex 15, CLIA and GAMPs Perform the quality review of equipment SOPs, policies and validation master plans for equipment implementations,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with legal and compliance as required. Proactively collaborate with other GxP quality representatives and act as QA point person for US and EU Medical Affairs ... and metrics. Support continuous process improvement, interpretation of regulations, quality and compliance with regulations and company standards,… more
- Merck & Co. (Durham, NC)
- … pharmaceutical /vaccine manufacturing facility. Demonstrated knowledge of GMPs, compliance issues, inspectional trends, industry quality assurance practices ... compliance requirements. FUNCTIONAL EXPERTISE: Specific to the following Quality Systems (Deviation Management, Complaints, Corrective Action/Preventive Action Management,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- … Assurance department and cooperation with various stakeholders to enhance quality and compliance across the organization.Job Responsibilities:Leadership & ... function, providing strategic direction and ensuring alignment with organizational goals. Quality and Compliance Oversight: Lead and/or participate in the… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- … System and by ensuring accountability for the efficient execution of critical quality tasks. Fostering efficiency, maintaining compliance with cGMP and other ... and offers an exceptional gateway to the fascinating world of fast-paced pharmaceutical manufacturing. The Quality Execution Coordinator will gain unprecedented… more
- Insmed Incorporated (San Diego, CA)
- …fast paced, collaborative, and multidisciplinary team. This individual will join the Quality Control leadership team. As the QC Stability and Sample Management ... for stability and sample management (eg, JMP, Labware LIMS)Collaborate with Quality Assurance, Manufacturing and CMOs, Material Management, and other functions to… more
- Tris Pharma (Monmouth Junction, NJ)
- … Quality Assurance provides strategic leadership and direction for Clinical Quality Assurance Operations, ensuring compliance with regulatory standards and ... has an immediate opening for a full-time permanent Director/Senior Director, Clinical Quality Assurance. This is a hybrid position. Job Title commensurate with… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …essential to an effective functioning of the various subunits of the Quality System and ensuring accountability. Achieving compliance with cGMP and ... documents, including Standard Operating Procedures, Work Instructions, Deviations, and other quality documents for cGMP compliance and consistency with FDA… more
- Merck & Co. (Durham, NC)
- Job DescriptionOur Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed ... aligned with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our internal manufacturing facilities, external… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything ... reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI products. This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes ... tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes… more
- BioAgilytix (San Diego, CA)
- …role/operations Not less than three (3) years' experience in GLP/GCLP/GMP quality assurance (QA) Experience working in biotech, pharmaceutical , CRO/CMO ... therapeutics to the patients who need them.Essential Responsibilities Performs Quality Assurance (QA) audits, inspections (internal/external), and monitoring procedures… more
- Merck & Co. (Rahway, NJ)
- …should have solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory, Operations, Non-clinical, ... This research opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global QMS to build a phase appropriate quality system that supports quality and compliance of Good Clinical Laboratory Practices and Good Laboratory ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and managed appropriately.… more
- Novo Nordisk Inc. (Durham, NC)
- …our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate ... three pharmaceutical manufacturing facilities that are responsible for fulfilling different...tactical & long-term strategic activities to drive process & compliance improvement within Bulk Process to ensure process &… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and 10 Essentials in all activities and interactions with othersSupport other quality compliance and implementation projects, as assignedOther Duties as ... weeks Paid Parental Leave Free access to Novo Nordisk-marketed pharmaceutical products At Novo Nordisk, you will find opportunities,...the Deviation Response Team team and a champion for quality priority principles and compliance within the… more
- Aequor (Parsippany, NJ)
- …rebate experience in pharm enviornment.- Prior Medicaid Claim processing experience with a Pharmaceutical and/or med Device company , state and/or state agency or as ... Medicaid consultant or equivalent work experience- Minimum 2&plus years pharmaceutical /product focused healthcare experience; Medicaid Claim processing function; manipulation… more
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