Are you look a Quality Assurance professional looking for an immediate position?
With over 40 years as a worldwide leader in the innovation and manufacturing of cell culture media, reagents, and medical devices for researchers and clinicians working in cell therapy and regenerative medicine, our client is looking to identify and hire a Quality Assurance ( QA) Support Specialist on a contract basis.
The Quality Assurance ( QA ) Support Specialist will be responsible for:
- Helping customers obtain requested information (RFQ, master files, quality questions, investigations, certificates, trending, summaries, follow up, etc.).
- Acting as customer liaison for internal inquiries and providing voice of customer.
- Coordinating customer surveys and questionnaires completed.
- Assisting with supplier questionnaires and qualification.
- Assisting with customer audits and follow up actions.
- Assisting with change notification and supplier management.
- Assisting with batch record review or other duties as needed.
- Assisting with coordination of quality activities for related production sites.
Requirements:
- BS/BA in Biology, Microbiology, or Chemistry preferred.
- 3-5 years of QA experience in medical device or biopharmaceutical environment.
- Must have chemistry or chemical knowledge.
- Must be familiar with FDA’s GMPs (QSR), ISO 13485, MDD 93/42, IVDD 98/79/EC, Health Canada and MDR requirements.
- Excellent computer skills including MS Word, Excel, PowerPoint.
- Excellent written and verbal communication skills.
