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Quality Assurance Specialist
- Permanent
- Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP)
- United States
This vacancy has now expired. Please see similar roles below...
Proclinical is currently recruiting for a Quality Assurance Specialist with a pharmaceutical company located in Bloomington, IN.
Job Responsibilities:
- 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.
- Influence and build relationship with internal and external partners to continuously enhance quality culture and business excellence.
- Interface with other functions (Operations, Planning, Technical Operations, Local Affiliates etc.) to meet patient supply requirements
- Apply cGMP regulations and other FDA and international requirements to all aspects of the position.
- Ability to work from home 20% depending on activity needs
Skills and Requirements:
- Bachelor's Degree with a concentration in science, or an equivalent technical discipline
- Minimum of 5 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
- Validation quality assurance experience is 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.
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