Overview
Quality Assurance Specialist Jobs in Durham, NC at Astrix
Title: Quality Assurance Specialist
Company: Astrix
Location: Durham, NC
Our esteemed client, a trailblazing global pharmaceutical powerhouse, renowned for their expertise in developing and manufacturing a wide array of world-class pharmaceutical drugs, life-saving vaccines, and innovative animal-health products, is in search of an exceptional Quality Assurance Specialist to join their dynamic team
Contract (1 year)
Up to 55/hr
Location: Durham, NC
Qualifications:
Quality Assurance professional with a minimum of a BS in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or equivalent.
At least 5 years of experience in the Pharmaceutical Industry.
Working knowledge of regulatory expectations for the manufacture and testing of sterile pharmaceutical products.
Experience in quality assurance oversight of sterile manufacturing, sterile process validation, and/or sterile process technology transfer.
Minimum of 3 years of experience with the development, review, and approval of User Requirement Specifications (URS), Factory Acceptance Testing (FAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for pharmaceutical and biotechnology manufacturing equipment, facilities, and utilities.
Responsibilities:
Preferred experience in assessing and preparing manufacturing sites for Pre-Approval inspections by Regulatory agencies for new products.
Reporting to the Quality Assurance Organization, independently manage project assignments.
Demonstrated interpersonal, communication, negotiation, and persuasion skills with strong relationship-building abilities.
Immediate project support on the review and approval of commissioning and qualification (C&Q) documents to support project delivery.
Provide QA support, including critical and constructive reviews and approvals of GMP documentation such as Quality Agreements, Quality Risk Assessments, URS, FAT, IQ, OQ, PQ, change management, and manufacturing/batch documents to meet schedule milestones.
Ensure all aspects of the project comply with cGMP, regulations, and the company’s Quality Management System.
Focus on areas such as Qualification and Compliance covering Manufacturing Equipment (isolator, restricted access barrier, incubator, washer, autoclave, formulation vessel, lyophilizer, etc.).
Review and approve master batch records, executed records, technical protocols, investigations, change controls, SOPs, validation protocols, and technical reports.
Consult with next-level manager on more complex decisions as needed.
This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!
