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. This is a build role rather than a maintenance role: the Specialist helps stand up the quality processes, systems, and documentation required for Oral Solid Dosage (OSD) and Sterile drug-product manufacturing—including aseptic processing and drug-substance operations—and ensures compliance with applicable GMP regulations and health-authority expectations.

Working with limited precedent, the Specialist exercises independent judgment to resolve quality issues of diverse scope, advises operations and cross-functional partners, and helps embed a “Right First Time” culture as the site progresses toward routine GMP operations. Work is performed independently and reviewed at critical points.

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.

• 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.

• Key Competencies
• Right First Time mindset: drives quality at the source and coaches others to do the same.
• Collaborative, organized, and systematic; brings structure to ambiguous and evolving situations.
• Clear communicator who adapts to both technical and non-technical audiences.
• Comfortable contributing in a dynamic, build-stage environment.

• Work Environment and Physical Requirements

  • 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.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.  Employees holding this position will be required to perform any other job-related duties as requested by Management.