- Kelly Services (South San Francisco, CA)
- …technical reports. + Assist in the preparation of regulatory submissions, including detailed review of data and reports to ensure alignment **Qualifications:** + ... on QMS procedures, quality standards, and regulatory requirements for internal staff. + Review and approve quality documentation, such as SOPs, batch records, and… more
- Drug Enforcement Administration (Arlington, VA)
- …of DEA. Policy Section (DPY) - Ensures the staff provide strategic policy review and advice regarding the CSA, federal regulations, and policy matters relating to ... pharmaceutical controlled substances and listed chemicals. Regulatory Drafting and...or her domain. Problem Solving: Engages in critical and data -driven thinking when diagnosing root causes and evaluating options.… more
- University of Michigan (Ann Arbor, MI)
- …+ The APP will complete detailed histories and physicals and present pertinent data to the medical staff. + Collect and interpret reports from diagnostic lab ... + Satisfactory completion of a Physician Assistant program accredited by Accreditation Review Commission on Education for the Physician Assistant (ARC-PA) or one of… more
- Merck (Durham, NC)
- …Vaccine Technology (GVTE), Automation, and Quality approvers. + Perform a thorough review of design & engineering records and related Good Manufacturing Practices ... in a timely manner, and implementing corrective actions to improve the execution/ review process for equipment. + Develop training material. Working as a subject… more
- Actalent (Blauvelt, NY)
- …cGMP and ISO standards. + Develop and communicate a monthly business review which includes performance and trending information. + Create and maintain performance ... recall and return of non-conforming raw material. + Track, review , and approve payroll for all quality assurance personnel...ISO, and in a highly regulated field such as pharmaceutical , food, auto, etc. + Experience with Lean Manufacturing… more
- Stryker (Los Angeles, CA)
- …business issues, including but not limited to medical device regulations, data privacy, competition law, anti-corruption / anti-bribery laws, liability avoidance, ... be based in Southern California. **What you will do:** + Draft, edit, review , and negotiate, with minimal supervision, various types of agreements, including Sales,… more
- Takeda Pharmaceuticals (Boston, MA)
- …executes a labeling implementation plan to incorporate new scientific, safety and clinical data , as well as Health Authority responses / feedback into CCDS, USPI and ... to Local Affiliates for responses to health authorities requests, review of local labeling exceptions and alignment deferrals, etc....(MSc, PhD, or PharmD) preferred. + 6+ years of pharmaceutical industry experience. This is inclusive of 4 years… more
- AbbVie (North Chicago, IL)
- …to work on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Demonstrates judgment within defined ... inspections and audits, providing DHF documentation as requested. + Documentation and Review : + Identify and address any gaps or discrepancies within the DHF.… more
- Takeda Pharmaceuticals (Lexington, MA)
- …events impacting schedule + request and execution of GMP documentation + Enter data in the Laboratory Information Management System (LIMS), MODA and other business ... system + Review manufacturing documentation real time to ensure compliance +...operations. + Ability to gown and gain entry to biotechnology/ pharmaceutical manufacturing areas. + May require weekend or holiday… more
- West Pharmaceutical Services (Tempe, AZ)
- …monitor and control the daily activities of quality inspection, testing, documentation review , and calibration in support of Operations and product release. This ... (Coordinate Measurement Machine), Vision Systems, and manual gaging. + Proactively analyze data and interpret results for any trending or OOS (out of specification)… more