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Quality Specialist - GMP Manufacturing
Apex Systems, Inc
West Point , PA 19486
Posted 2 months ago
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Description Responsibilities: Responsible for ensuring that all company products are manufactured, packaged, analyzed, released stored and distributed in accordance with internal expectations and all applicable regulatory requirements.
Ensures the Quality performance of external parties/partners through direct oversight, support and counselling to the partners Quality unit. These activities include involvement in most aspects of external manufacturer operations related to the quality of products produced. Responsible for the release of all manufactured products and to assure they have been produced from approved processes in conformance to all applicable regulatory requirements and Company policies.
Exercises a leadership role in monitoring and maintaining Biologics External Manufacturing (BEM) compliance with the FDC Act, Current Good Manufacturing Practices Regulations (domestic and foreign) and other pertinent legal requirements.
BS degree or equivalent in Biology, Microbiology, Pharmacy, Chemistry, Biochemistry, Chemical Engineering, Biomedical Engineering, etc. a must 5+ years experience in the pharmaceutical industry with a thorough knowledge and broad experience of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements. Must have strong demonstrated interpersonal, communication, negotiation, and persuasion skills.
Communicates easily in English both verbally and in writing. Must have very strong relationship building skills. Experience with biologic and/or vaccine Quality Assurance and Quality Control preferable.
Experience with SAP based MRP platform and Trackwise change control and customer complaint applications desired Knowledge of contractual and financial awareness a plus EEO Employer Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.
If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or . VEVRAA Federal Contractor We request Priority Protected Veteran & Disabled Referrals for all of our locations within the state. We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. The EEO is the Law poster is available here.