Carex is partnering with a Pharmaceuticals industry partner to find a Quality Assurance Engineer who will support ongoing development programs for preclinical and clinical drug candidates. This role plays a critical part in maintaining and enhancing quality systems that align with Good Manufacturing Practices (GMP). The ideal candidate will act as a Quality Assurance subject matter expert (SME) in validation and qualification efforts, ensuring the integrity and compliance of systems, processes, and documentation across the organization.
What You’ll Do
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Serve as the QA subject matter expert for system and process validation activities, including risk assessments, system design, and documentation reviews.
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Provide quality oversight for data integrity across systems and processes.
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Support and manage internal deviations, change controls, and CAPAs through review and approval.
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Draft, review, and approve procedures that support validated systems and GMP-compliant processes.
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Lead or contribute to the implementation of periodic reviews of validated systems and processes.
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Review and approve internal and vendor documentation for equipment, instrumentation, and facility qualification and commissioning.
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Perform final release of systems and instruments for GMP use.
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Utilize and support the use of an electronic document management system (e.g., Veeva QualityDocs).
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Release controlled documents such as logbooks and labels; conduct quality reviews of completed forms and verifications.
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Support internal and external audits with appropriate documentation and expertise.
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Perform additional quality assurance duties as required.
What You’ll Bring
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Bachelor’s degree or higher in a scientific discipline.
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Minimum of 4 years of experience in cGMP-regulated manufacturing environments, with a focus on quality assurance and process lifecycle management.
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Strong working knowledge of GMP regulations, including 21 CFR Parts 11, 210, 211 and EU GMPs (Annex 11 and 15).
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Proficiency in Microsoft Word and Excel.
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Ability to follow standard operating procedures and work independently with minimal supervision.
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Excellent organizational skills, attention to detail, and ability to manage multiple priorities.
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Strong interpersonal and communication skills, both verbal and written.
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Prior experience with electronic document management systems in regulated environments is preferred.
Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity, or Veteran status.
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