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Quality Documentation Associate - Gmp, Trackwise
Apex Systems, Inc
Lansdale , PA 19446
Posted 4 months ago
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Responsibilities: Responsible for GMP document management and the generation of reports to support team compliance and GMP release decisions in conformance to all applicable regulatory requirements and company policies.
Performs & oversees document management & administrative filing across stakeholder areas to ensure compliance. Must be flexible and collaborative to support departmental needs as requested. Runs queries from SAP and TrackWise to support compliance monitoring and GMP activities Assures compliance with established internal policies and procedures and complies with all applicable governmental regulations (GMP, etc.), both domestic and foreign.
Operates in a safe and efficient manner and in compliance with the internal QO Safety and Health Policy.
BS degree or equivalent in Biology, Microbiology, Pharmacy, Chemistry, Biochemistry, Chemical Engineering, Biomedical Engineering, etc. required 2+ 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. Experience with MIDAS and document management Strong collaboration, organizational and project management skills Must be able to communicate easily in English both verbally and in writing.
Experience running report queries from SAP and TrackWise system platforms preferred 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.