Quality Assurance Specialist

Piper Companies is currently looking for an experienced Quality Assurance Specialist in Rahway, New Jersey (NJ) to work for a leading pharmaceutical manufacturer. The Quality Assurance Specialist will play a significant role in the oversight and regulatory compliance of cell therapy manufacturing.

Responsibilities for the Quality Assurance Specialist include:
• Review clinical/commercial electronic batch records and documentation for completeness and accuracy in preparation for batch release
• Correct and revise documentation as needed
• Advise manufacturing personnel on proper documentation
• Utilize knowledge of FDA and GMP regulations to ensure compliance
• Assist in Deviation/OOS investigations

Qualifications for the Quality Assurance Specialist include:
• A minimum of 1-5 years' experience within Pharmaceutical Manufacturing
• Hands on experince with Batch Record review
• Proficiency in Microsoft Office
• B.S. in business or scientific field preferred

Compensation for the Quality Assurance Specialist include:
• Salary Range is $65,000-$85,000 dependent upon experience.
• Comprehensive benefits package

Keywords

Quality Assurance Associate, QA, Pharmaceutical, Rahway, NJ, New Jersey, FDA, GMP, Batch Record, Manufacturing, GDP, cGMP, Clinical Manufacturing, Regulatory Review