Quality Assurance (QA) Specialist

Piper Health and Sciences is actively seeking a QA Specialist to work for biotechnology company focusing on protein engineering. This an onsite role in the greater Bedford PA area with flexibility to work 1-2 days at home.

Responsibilities for Quality Assurance (QA) Specialist:
•Oversee quality assurance activities including batch record review, lot release, material release, non conformances, and product complaints to ensure compliance with ISO 13485
•Maintain quality management system (QMS) including document control, deviation management, and change controls
•Oversee supplier quality and vendor management including quality agreements and audits
•Responsible for reviewing and approving deviations, investigations, bill of materials, and change controls
•Ensure timely close out of all investigations, assist with root cause analyses, oversee change controls, and write up corrective action and preventative actions (CAPAs)
•Assist in reading, reviewing and revising process improvement plans
•Review, draft, edit and approve SOPs and specifications

Technical Requirements for Quality Assurance (QA) Specialist:
•Bachelor's degree in biology, chemical engineering, biochemistry, or related field
•Minimum 2 years of experience working in a pharmaceutical or biotechnology environment
•At least 2 years of experience with ISO 13485
•At least 2 years of experience with deviations, investigations, change controls, batch record review and CAPAs
•Excellent organizational skills and proven experience working in a fast-paced environment

Compensation & Benefits for Quality Assurance (QA) Specialist:
•Compensation: $60,000-80,000 based on previous salary history and experience
•Full Benefits: Medical, Dental, Vision, 401k, PTO, Relocation Assistance, etc
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