Johnson Service Group
Johnson Service Group (JSG) is currently looking for a SeniorQA Specialist. This is a contract hire opportunity with one of the world’s premier research-intensive biopharmaceutical organization and is located in Durham, NC. Hourly rate $55.00 Qualifications: Quality Assurance professional with at a minimum a BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) and at least 5 years experience in the Pharmaceutical Industry. Would consider Associates w/good relevant experience Must have working knowledge of regulatory expectations for the manufacture and testing of sterile pharmaceutical products with experience in quality assurance oversight of sterile manufacturing, sterile process validation and/or sterile process technology transfer. Responsibilities: Preferred experience in the assessment and preparation of manufacturing sites for Pre-Approval inspections by Regulatory agencies for new products. • Must have strong demonstrated interpersonal, communication, negotiation, and persuasion skills. Responsibilities to include but not limited to the following: • Batch record review/approval • Technical protocol review/approval • Equipment qualification protocol review/approval • Deviation review/approval • Execute shop floor quality audits Comments/Special Instructions familiar w/SAP. PAS-X, Manufacturing Execution System would be a plus, familiar with SAP a plus These positions are more traditional Quality Assurance type stuff as the project has moved past most of the qualification stages... • Batch record review/approval • Technical protocol review/approval • Equipment qualification protocol review/approval • Deviation review/approval • Execute shop floor quality audits Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law. Allen Mudalel (610) 828-7356 amudalel@jsginc.com 515 Grove St. Suite 3G • Haddon Heights, NJ 08035 • jsginc.com