What are the responsibilities and job description for the Quality Assurance Specialist II position at Prosolus, Inc.?
We are seeking a detail-oriented and proactive Quality Specialist II to join our team. This role is critical in ensuring that all products meet the highest standards of safety, compliance, and quality. The ideal candidate will have experience in quality assurance and regulatory compliance, strong analytical skills, and the ability to collaborate effectively with production, quality control, customers and suppliers.
Essential Duties and Responsibilities:
Review documentation related to the receipt, inspection and sampling of incoming materials, and the manufacturing of in-process and finished products. Review of manufacturing records for completeness and adherence to the current Good Manufacturing Practice (CGMP) and Good Documentation Practice (GDP). Release material for production use. Monitor production runs for adherence to product specifications and compliance with regulatory requirements. Compile and evaluate information to improve quality, manufacturing systems and regulatory compliance. Perform Document Control functions.
Education and Experience:
Bachelor’s degree (B.S. or B.A.) from a 4-year college or university. 3 years of Quality Assurance experience in a regulated industry, preferably in the pharmaceutical/biological product or medical device manufacturing environment.