Quality Assurance Specialist
Proclinical is currently recruiting for a Quality Assurance Specialist with a pharmaceutical company located in Baltimore, MD.
- Support the effective and compliant execution of tech transfer activities and development of necessary quality systems at the manufacturing sites and associated off-site storage locations.
- Support site qualification activities and development of quality agreements in accordance with company standards.
- Perform review and approval of equipment and facility qualification, technical documents, raw material specifications, analytical methods, and master batch records to ensure company products/processes comply with cGMP requirements.
- Support regulatory submission activities, and lead inspection readiness activities in partnership with external manufacturing site and our client to support global health authority approvals.
- Following successful tech transfer, support quality oversight for day-to-day production activities, including deviation and CAPA management, escalation of critical issues, and change control.
- Monitor external manufacturing quality performance and proactively identify risks and mitigation plans through benchmarking and knowledge sharing.
- Apply cGMP regulations and other FDA and international requirements to all aspects of the position.
Skills and Requirements:
- Bachelor's degree with a concentration in science, or an equivalent technical discipline
- Minimum of 8 years working in an FDA regulated environment
- Experience in pharmaceutical aseptic manufacturing operations and quality assurance
- Detailed knowledge of cGMPs related to pharmaceutical production
- Strong interpersonal and written/oral communication skills
- Ability to quickly process complex information and make critical decisions with limited information required
- Advanced degrees are a plus and may reduce the experience required
If you are having difficulty in applying or if you have any questions, please contact Brianna Copeland at 617-830-7546.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.