Quality Assurance Specialist

Piper Clinical Solutions is actively seeking a Deviations and Investigations Specialist to work at a large biotechnology company in the greater Albany New York area. This position has flexible hours and work from home / remote flexibility. Responsibilities for Quality Assurance Specialist:

• Write up deviations and investigations for manufacturing, environmental monitoring and manufacturing sciences for downstream and upstream manufacturing processes.
• Ensure GMP and FDA compliance on the manufacturing floor through documentation review and batch record review.
• Conduct investigations on the manufacturing floor, conduct root cause analysis, then write up corrective action and preventative actions.
• Oversee deviation close outs, investigations, validation, validation reports, CAPA implementations, and change controls
• Assist in reading, reviewing and revising SOPs and assist in process improvement plans.

• Bachelor's degree in biology, chemical engineering, biochemistry, or related field.
• Minimum 5 years of experience working in a pharmaceutical or biotechnology GMP regulated environment.
• At least 3 years of experience with technical writing in a pharmaceutical manufacturing environment.
• Excellent organizational skills and proven experience working in a fast-paced environment.

• Compensation: $70,000-120,00 based on previous salary history and experience
• Full Benefits: Medical, Dental, Vision, PTO etc