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