Senior Quality Assurance Specialist – Biotechnology – ISO 13485

Senior Quality Assurance Specialist – Biotechnology Company in Swedesboro- Med Devices – ISO 13485 – up to $115K

This Jobot Job is hosted by: Grace Brewer
Are you a fit? Easy Apply now by clicking the “Apply on company site” button and sending us your resume.
Salary: $80,000 – $115,000 per year

A bit about us:

We are a 300 Person Biotechnology company that specializes in Design, R&D, and Manufacturing of Diagnostics products that are accurate, repeatable, and easy to use. We are the region’s leading provider of assays and reagents for specialty indications and applications in the biotechnology market.

We are looking for a Senior Quality Assurance Specialist with knowledge and understanding of cGMP manufacturing and ISO 13485 standards to join our award-winning team.

Why join us?

• Competitive compensation – up to $115K
• Generous benefits package with excellent health insurance
• Work for a meaningful cause & help our customers solve their cell culture challenges!
• Surround yourself with top industry talent
• Join a stable and rapidly growing company
• Promotes work/life balance

Job Details

Candidate Qualifications:

• BS in a life science or related discipline
• 5+ Years in a Quality role or GMP environment
• ISO 13485 experience

Primary Job Duties:

• Oversee daily operational activities and ensure adherence to pertinent regulatory requirements
• Review, revise and approve (GMP QA) SOPs, protocols/batch records, reports, and other quality and regulated records
• Management of Nonconformance, CAPA, OOS systems.
• Participate in the preparation and review of QA files in preparation for site visits and regulatory inspections; assure that QA audit files are retained.

Interested in hearing more? Easy Apply now by clicking the “Apply on company site” button.