- Merck (Annapolis, MD)
- **Job Description** The Director of GMP Compliance will be a part of the Compliance Support and Remediation team within our company's Global Quality ... SMEs. **Job Function:** + serve as a subject matter expert for good manufacturing practices ( GMP ) for...authority/board of health as an inspector, investigator, product reviewer, compliance officer, or other GMP /regulatory role +… more
- Catalent Pharma Solutions (Baltimore, MD)
- …meet quality expectations needed to assure patient safety. Providing QA support for GMP Raw Materials that support the production of GMP Manufacturing ... is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer and Catalent employee. **The… more
- Catalent Pharma Solutions (Harmans, MD)
- …is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer and Catalent employee. **The ... timely resolution; responsible for and administers the CAPA Tracking System for general GMP use and internal audits. Track the timely completion and extension of… more
- Catalent Pharma Solutions (Hanover, MD)
- …and 21 CFR part 11 + Hands on experience with an EDMS creating documents for a GMP environment. + Expert in formatting in Microsoft Word and use of edit tools. + ... a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer,...and maintenance of executed manufacturing batch records and supporting GMP documentation to support batch disposition + Review of… more
- Catalent Pharma Solutions (Harmans, MD)
- …Records and SOPs to support GMP manufacturing projects + Working with GMP Manufacturing as an on-the-floor Subject Matter Expert (SME) + Working closely ... processes. The individual will serve as a subject matter expert (SME) for biologic Upstream Processes and/or Downstream Processes....a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer… more
- Catalent Pharma Solutions (Harmans, MD)
- …of general GMP practices + Experience in writing SOPs + Expert experience with biochemistry, as well as generating/reviewing the documentation that supports such ... the Quality Control (QC) group. The Supervisor, QC must demonstrate expert technical knowledge, mentors direct reports on basic scientific/regulatory principles,… more
- Fujifilm (Annapolis, MD)
- …regard to biologically contaminated solid waste materials, serve as the subject matter expert for laboratory safety, be a resource to EHS teams for facility safety ... audits, and represent FDB as a biosafety subject matter expert . This role will have 7-10 direct and indirect...certifications, and related work experience. + Strong understanding of GMP principals and working within a quality centric organization… more
- Catalent Pharma Solutions (Harmans, MD)
- …is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer and Catalent employee. **The ... agreements on behalf of Gene Therapy sites to assure compliance with Catalent expectations; manages & advises team assessing...a Life Sciences discipline and 10+ years of relevant GMP experience required, CMO/CDMO experience preferred * 2+ years… more
- Kelly Services (Baltimore, MD)
- …results, and maintain accurate laboratory notebooks. + Follow written instructions and ensure compliance with GMP , GLP, FDA, RCRA, and OSHA standards. + ... analytical methods. + Knowledge of industry standards and regulations ( GMP , GLP, FDA, RCRA, OSHA) may be required. As...hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical… more