Quality Assurance Specialist - Pharmaceuticals
On-siteMiddletown, Delaware, United States
Job Summary
Provide independent on-the-floor quality assurance support to manufacturing and operations, including real-time batch record review and timely disposition of quality events during production. Help establish and document the site quality management system by authoring SOPs, work instructions, and job aids for sterile and drug-product operations to meet FDA and EMA requirements. Own quality events end to end, applying structured problem-solving to deviations, investigations, root-cause analysis, CAPAs, and change controls. Review commissioning, qualification, and validation documentation, lead readiness inspections of manufacturing areas and equipment, and support new product introduction activities with quality oversight. Design and deliver GMP training to build capability and a sustained "Right First Time" culture. Serve as a quality subject-matter expert for internal, client, and regulatory inspections while ensuring complete, accurate records in accordance with Good Documentation Practices and data-integrity principles.
Required Qualifications
- Bachelor's degree in scientific or engineering discipline, or an equivalent combination of education and directly relevant experience
- Approximately five years of pharmaceutical or biopharmaceutical quality assurance experience, or an equivalent combination of education and directly relevant experience, including hands-on time in a GMP manufacturing environment
- Experience supporting a greenfield site or new-facility start-up and standing up QMS processes from the ground up, or experience with New Product Introduction (NPI)
- Experience working in a multiproduct pharmaceutical manufacturing facility, including managing differing customer requirements and the controls used to prevent cross-contamination between products
- Demonstrated, hands-on understanding of both manufacturing/production operations and quality assurance
- Direct experience with sterile drug-product manufacturing and aseptic processing in a GMP setting
- Demonstrated ownership of core QMS elements—deviations, investigations, root-cause analysis, CAPA, and change control—including the ability to explain the rationale and compliance basis behind each
- Working knowledge of applicable GMP regulations and ICH guidelines, and the ability to apply them to operational decisions
- Strong Good Documentation Practices and data-integrity (ALCOA+) discipline
- Experience operating within an electronic quality and/or document management system
- Excellent written and verbal communication, with the ability to influence and align stakeholders across functions and levels
- Ability to work independently with limited precedent, exercising sound judgment and seeking review at critical decision points
- Experience with electronic QMS / document-management platforms such as Veeva Vault and SAP
- Experience supporting audits and inspections, including backroom management and subject-matter-expert preparation
- Quality or auditing certification (for example, ASQ CQA, CQE, or CMQ/OE)
- Familiarity with risk-management tools (for example, FMEA) and statistical process control concepts
- Composed and credible in client-facing and inspection settings
- Familiarity with AI regulations to ensure the data is secure and understanding of the data-integrity and confidentiality risks associated with unvalidated AI tools
- Work in a GMP manufacturing environment, including cleanroom and classified areas that require gowning and adherence to aseptic behaviors
- Periods of standing, walking, and on-floor presence during production
- Occasional travel for audits
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