Quality Assurance Specialist

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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