- Bristol Myers Squibb (Devens, MA)
- …production. + Provide investigation support for production related investigations, ensuring compliance with internal standards and regulatory requirements. + ... cause analysis and CAPAs). + Support inspection readiness and actively support regulatory inspections and ensure safe and compliant cGMP operations. + Review and… more
- Actalent (La Verne, CA)
- …supplies, performing general laboratory maintenance, and maintaining accurate records in compliance with company and regulatory standards. Responsibilities + ... Keep accurate manual and electronic records in accordance with company and regulatory policies. Essential Skills + Experience in the biotechnology or … more
- Mallinckrodt Pharmaceuticals (Hobart, NY)
- …Improves safety, quality, and productivity of a fast-paced solid dose pharmaceutical operation. Consistently seeks for and evaluates methods to improve overall ... problem resolution in support of routine daily production, Safety, Quality Compliance , and schedule adherence. New Product Launch Facilitated in Department Assist… more
- AbbVie (Mettawa, IL)
- …as on-market products that effectively and efficiently meets ethical, scientific, regulatory , commercial, and quality requirements + In the post-marketing setting, ... support of pipeline development and on-market product support. Experience within pharmaceutical industry preferred. + Must perform at times in previously uncharted… more
- Actalent (Frederick, MD)
- …meetings. * Monitor the GMP systems currently in place to ensure compliance with documented policies. Review proposed changes to systems, procedures, methods, and ... submissions to regulatory agencies, as appropriate. * Gather metric information for...Part 11/210/211). * Preferred: Experience in the biotech and/or pharmaceutical industry. Experience Level Entry Level Pay and Benefits… more
- Actalent (Princeton, NJ)
- …+ Interact with clients and health authorities to ensure quality standards and regulatory compliance . Essential Skills + Master's degree with 1+ years of ... experience in the pharmaceutical industry or GMP environment, focusing on analytical methods...experience with a comprehensive understanding of compendial methods and regulatory guidance. + Ability to manage multiple priorities and… more
- Gilead Sciences, Inc. (Oceanside, CA)
- …development across all stages-from early development to commercial launch-as well as regulatory filing experience with the FDA and EMA. A deep understanding of ... execute experiments to support development and investigations. + Collaborate across Pharmaceutical Development & Manufacturing (PDM) and partner with Quality, Supply… more
- BeOne Medicines (San Mateo, CA)
- …and/or medical devices * Conduct site visits to determine protocol and regulatory compliance , and prepare required documentation * Develop collaborative ... processes with a thorough knowledge of ICH and associated regulatory guidelines * Minimum of 4-6 years of relevant...of 3-4 years of (CRA) monitoring experience in the pharmaceutical or CRO Industry * Excellent communication and interpersonal… more
- Veterans Affairs, Veterans Health Administration (Salisbury, NC)
- …service programs operate at a satisfactory level of performance and in compliance with regulatory and accrediting bodies. Responsible for pharmacy utilization ... and adverse drug reactions are informative, accurate and timely. Ensures that pharmaceutical care and direct patient care activities of subordinates are documented… more
- UNC Health Care (Goldsboro, NC)
- …job-specific functions. 8. Contributes to process improvement projects. 9. Completes regulatory compliance inspection of medication storage areas, including ... area and returns unused medications to the pharmacy. 3. Documents pharmaceutical activities including filling of medication orders, quality control requirements etc.… more