Quality Assurance Specialist - Pharmaceuticals

About The Company

The Quality Assurance Specialist is a fully qualified quality professional who provides independent, on-the-floor quality assurance support to manufacturing and operations while the site’s GMP quality system is being established.

Key Responsibilities

• 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 (QMS), authoring and improving SOPs, work instructions, and job aids for sterile/aseptic and drug-product operations to meet FDA, EMA, and other applicable health-authority requirements.
• Own quality events end to end—deviations, investigations, root-cause analysis, CAPAs, change controls, and effectiveness checks—applying structured problem-solving to events of diverse scope and limited precedent.
• Review commissioning, qualification, and validation (CQV) documentation, including URS, FAT/SAT, turnover packages, IQ/OQ/PQ, and process validation.
• Lead readiness inspections of manufacturing areas, equipment, computerized systems, and processes to identify and mitigate quality risks prior to operational start-up.
• Support new product introduction (NPI) and technology-transfer activities, providing quality oversight of batch records, bills of materials, and related documentation to enable right-first-time execution.
• Design and deliver quality and GMP training, and coach operations and quality colleagues to build capability and a sustained “Right First Time” culture during this formative period.
• Serve as a quality subject-matter expert for internal, client, and regulatory inspections, and advise stakeholders toward sound and compliant decisions.
• Ensure complete, accurate, and contemporaneous records in accordance with Good Documentation Practices and data-integrity (ALCOA+) principles, including appropriate use of electronic QMS and document-management systems and other validated digital quality tools.
• Partners across manufacturing, engineering, and validation functions to integrate quality requirements into daily operations.

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.
• Able 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.