- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …relating to the verification programs. + Conducts audits and/or coordinates with USP GMP auditors at USP Rockville and at USP international sites to provide ... and internationally **Additional Desired Preferences** + Extensive knowledge of FDA regulations pertaining to cGMP requirements. + Knowledge of...to cGMP requirements. + Knowledge of and experiences with GMP audits using 21 CFR parts 111 and 117… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …quality control of dietary supplements and/or pharmaceuticals. * Knowledge of and experience with GMP audits using 21 CFR parts 111 and 117 is required. * Working ... management experience. **Additional Desired Preferences** * Extensive knowledge of FDA regulations pertaining to cGMP requirements and proficiency with regulation… more
- United Therapeutics (Silver Spring, MD)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... Reconcile calibration documentation in accordance with internal procedures and FDA guidelines. Support investigation and closure of calibration-related deviations… more
- Charles River Laboratories (Rockville, MD)
- …all strategic initiatives, Operations, functional support organizations, and execution of GMP activities at the Rockville site. This position interacts regularly ... Excel, Outlook, etc.) is essential * Understanding/familiarity with relevant FDA , EMA, ICH, USP and EP guidelines and regulations...drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to… more
- Jabil (Hunt Valley, MD)
- …Practices (GLP), and related company standard operating procedures (SOPs), state, FDA , local laws and international (eg, EU, Chinese, Japanese) as applicable ... laboratory personnel to correct any errors and omissions in GMP documentation and promote a cGMP culture. Ability to.... Familiarity with cGMP, GLP, and regulatory compliance standards ( FDA , EMA, ICH). + . Proficient in Microsoft Office… more
- Charles River Laboratories (Bethesda, MD)
- …by delivering operational and cost efficiencies through the strategic insourcing of GMP , GLP and non-GLP research services from discovery through safety assessment. ... have proudly supported the development of 80% of the drugs approved by the FDA for the past 3 years. **Equal Employment Opportunity** Charles River Laboratories is… more
- Charles River Laboratories (Bethesda, MD)
- …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
- ThermoFisher Scientific (Frederick, MD)
- …lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Some degree of PPE (Personal Protective Equipment) required ... potentially hazardous properties. + Ensures compliance with SOPs, facility safety rules, and FDA requirements, such as cGMP CFR parts 210 and 211. + Role models… more
- ThermoFisher Scientific (Frederick, MD)
- …lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Some degree of PPE (Personal Protective Equipment) required ... in process improvement activities. + Ensures compliance with SOPs, facility safety rules, and FDA requirements, such as cGMP CFR parts 210 and 211. + Role models… more
- Charles River Laboratories (Bethesda, MD)
- …by delivering operational and cost efficiencies through the strategic insourcing of GMP , GLP and non-GLP research services from discovery through safety assessment. ... proudly supported the development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories is an Equal… more