- Charles River Laboratories (Boston, MA)
- …by delivering operational and cost efficiencies through the strategic insourcing of GMP , GLP and non-GLP research services from discovery through safety assessment. ... worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits that elevate your… more
- Bristol Myers Squibb (Devens, MA)
- …in a manner consistent with the safety policies, quality systems, and GMP requirements. + Completing training assignments to ensure the necessary technical skills ... requirements. **Knowledge and Skills:** + Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred.… more
- Charles River Laboratories (Cambridge, MA)
- …by delivering operational and cost efficiencies through the strategic insourcing of GMP , GLP and non-GLP research services from discovery through safety assessment. ... worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits that elevate your… more
- Stantec (Boston, MA)
- …related to bio-pharmaceutical dosage forms, nutraceutical facilities and other regulated FDA or similar facilities where drug products are manufactured, stored in ... GMP conditions and distributed, including computerized and automated systems which require qualification and validation for compliance. The commissioning and… more
- System One (Harvard, MA)
- …discipline, or its equivalent is preferred. + Advanced Level of relevant experience in a GMP , GCP, or GXP with at least 8 years focused on product quality. Preferred ... integrity principles + Proven attention to details + Comfortable working in an FDA regulated environment. System One, and its subsidiaries including Joule, ALTA IT… more
- Charles River Laboratories (Boston, MA)
- …by delivering operational and cost efficiencies through the strategic insourcing of GMP , GLP and non-GLP research services from discovery through safety assessment. ... worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits that elevate your… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …will be responsible for planning, executing, and documenting validation activities to meet FDA and potentially other global regulatory standards such as 21 CFR Part ... Must have experience in a pharmaceutical or biopharmaceutical manufacturing facility; GMP experience is required. Experience with ERP, LIMS, QMS and other… more
- Charles River Laboratories (Cambridge, MA)
- …by delivering operational and cost efficiencies through the strategic insourcing of GMP , GLP and non-GLP research services from discovery through safety assessment. ... worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits that elevate your… more
- Charles River Laboratories (Cambridge, MA)
- …by delivering operational and cost efficiencies through the strategic insourcing of GMP , GLP and non-GLP research services from discovery through safety assessment. ... worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits that elevate your… more
- Zimmer Biomet (Braintree, MA)
- …Assist and lead audits, both internal and external, to demonstrate compliance with GMP , ISO, CMDR, and MDD regulations. + Support coordination of field action ... Out** + Excellent working knowledge of current USA Food and Drug Administration ( FDA ) and global laws, regulations and standards. + Familiarity with statistical data… more