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Quality Assurance Specialist

Company: Apex Systems
Location: Montgomery
Posted on: November 19, 2020

Job Description:

Apex Systems has an exciting opportunity for a QA Specialist for one of our Pharmaceutical clients located near Lansdale, PA. The QA Associate will support the continued development and implementation of a practical quality management system. Must possess a quality oriented mind and technical knowledge to complement interpersonal skills of flexibility and collaboration. Effectively communicate and maintain open and timely execution of QA tasks across multi-disciplinary teams. Role and responsibilities Review and providing feedback on GMP documentation including equipment qualifications, analytical method qualifications, stability protocols, product monographs, and SOPs. Review and release raw materials and components to be used in the manufacture of clinical andor commercial products. Provide QA support and oversight during the production and testing of drug product. Review executed batch records, analytical test results and raw data as part of product release. As required, work to resolve identified issues to support timely release of product that conforms to specifications. Support and review investigations related to deviations or out-of-specifications and the implementation of corrective and preventive actions that mitigate potential for reoccurrence. Communicate quality-related input to project teams while participating in project or client meetings. Provide new employee orientation and curricula issuance in coordination with department heads. Ensure ongoing employee compliance with training procedures. Participate in the planning and execution of customer audits. As required, support the drafting of responses to client audit findings to assure they meet the client's expectations. Participate in regulatory inspections to ensure successful results. Participate in supplier quality assessments to ensure suppliers and subcontractors to be used are properly qualified in accordance with the supplier management program. Education and Experience Requirements Minimum of a Bachelor's degree in a scientific field, or equivalent experience Minimum three (3) years related experience in QA or five (5) years in QC Strong analytical skills and attention to details required Must have a Chemistry background in Pharmaceuticals. IT QA experience will not be considered. For immediate consideration, email a copy of your resume to David Neto at EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, 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

Keywords: Apex Systems, Montgomery , Quality Assurance Specialist, Other , Montgomery, Alabama

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