Quality Assurance Specialist

4 weeks ago


Rahway, New Jersey, United States AA2IT Full time

{"Responsibilities": "The Quality Assurance Specialist for Small molecule is responsible for managing deviations and customer complaints, including coordination, review, and approval of deviations and complaint investigations. Key activities include reviewing and approving deviation reports, notifying external manufacturing sites of customer complaints, reviewing and approving complaint investigations, and collaborating with other team members to perform second-person reviews of stability protocols.", "Qualifications": "A Bachelor's or Master's degree in Biology, Microbiology, Pharmacy, Chemistry, or Chemical Engineering is required, with a minimum of 4-6 years of relevant experience in complaints management, deviations, and complaint investigations. Experience in the pharmaceutical industry or Medical Devices Combination Products with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control is essential.", "Requirements": "Expertise in managing deviations within customer complaints, experience with CMO's and external manufacturing sites, understanding of regulations, expertise in investigation and CAPA, and potential experience with inspections and audits are required. Proficiency in SAP, Trackwise, and Veeva is also necessary.", "Industry Expertise": "Pharmaceuticals/Medical device/drug products/sterile products/Combination Products", "Software": "SAP, Trackwise, Veeva", "Location": "Remote", "Compensation": "$45-$47/HR on W2"}



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