- Charles River Laboratories (Rockville, MD)
- …to provide guidance and strong quality leadership + Manages and schedules Quality Assurance personnel for support of CGMP operations + Monitors projects and ... of achievable solutions + Manages the walkthrough program in GMP Manufacturing, quality control testing, storage and...investigations and risk assessments + Previous experience as an auditor for internal and vendor audits + Ability to… more
- Charles River Laboratories (Rockville, MD)
- …business and/or gene-modification modalities, cell-based gene therapies. + ISO Lead Auditor training, desirable + Certified Quality Engineer (ASQ), desirable ... passionate about. **Job Summary** This position reports to the Site Head of Quality , and the person filling this role is responsible for partnering with functional… more
- Terumo Medical Corporation (Elkton, MD)
- …assigned. **Knowledge, Skills and Abilities (KSA)** Knowledge: + Deep understanding of quality assurance principles and documentation control. + Strong knowledge ... of quality management systems and regulatory standards (eg, ISO, GMP ). + Proficient in document management software and methodologies. + Exceptional writing… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …with regulation and guideline interpretation, audit procedures, proper documentation, and Quality Assurance . + Certificate from the American Society for ... verification programs. + Conducts audits and/or coordinates with USP GMP auditors at USP Rockville and at USP international... Quality (ASQ) as a Certified Quality Auditor (CQA) is desirable. + Working… more