QA Manager (982335)
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New Castle, DE 19729
This position contributes to the Company’s success by initial establishment of ISO quality system (ISO 9001:2015), followed by upgrade to cGMP manufacturing.
Summary of Key Responsibilities:
Lead the establishment of quality systems and procedures to ensure compliance with all applicable laws, regulations in support of cGxP activities
Establish ISO quality systems (ISO 9001:2015) including quality management system, facility, equipment, and production.
Prepare SOPs required for compliance
Lead all aspects of quality systems: change control, deviations, investigations, complaints and CAPA systems to assure timely compliance with quality requirements
Lead quality compliance efforts including site training, supplier management, internal audits and related functions.
Manage the QA batch review and release function for cGMP manufacturing of intermediates and API’s
Contribute to preparation and/or review of annual product review and updates for regulatory filings, batch release metrics and department reporting, as applicable
Participate in cross-functional teams in preparation for regulatory inspections, quality and technical agreements, internal and external auditing, validation activities and special projects
May possibly participate in relevant external site audits
Bachelor’s or higher degree with scientific or engineering emphasis required
Professional certification is preferred (i.e., CQA, Six Sigma, CQM, CQA, CQE)
10+ years’ experience working in pharmaceutical manufacturing setting in Quality Assurance, including implementation of ISO 9001: 2015, final closure review of deviation / non-conformance investigations and batch disposition determination
Experience interfacing with regulatory agencies (g., FDA), including relevant contributions to INDA and NDA documentation
Strong background in analytical services is preferred
Strong understanding of GMP, including 21 CFR 210 and 211, ICH guidelines and FDA requirements for pharmaceuticals
Prior experience in leading quality team at CMO is highly desired; CTL and packaging / labeling
Excellent written and oral communication skills
For Consideration, please email your resume to Eschaffer@apexsystems.com
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.
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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.https://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf