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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