Quality Assurance Specialist (Pharmaceuticals)

TL;DR

Quality Assurance Specialist (Pharmaceuticals): Establishing and supporting GMP quality systems for pharmaceutical manufacturing with an accent on Oral Solid Dosage (OSD) and sterile drug-product operations. Focus on standing up QMS processes, authoring SOPs, and ensuring compliance with FDA and EMA regulations during a greenfield site startup.

Location: On-site in Middletown, DE

Company

WuXi STA is building new pharmaceutical manufacturing capability and establishing the quality systems that will support it.

What you will do

• Provide independent on-the-floor QA support for manufacturing and operations, including real-time batch record review.
• Establish and document the site Quality Management System (QMS) and author SOPs to meet FDA and EMA requirements.
• Manage quality events end-to-end, including deviations, investigations, root-cause analysis, CAPAs, and change controls.
• Review CQV documentation (URS, FAT/SAT, IQ/OQ/PQ) and lead readiness inspections of manufacturing areas and equipment.
• Support New Product Introduction (NPI) and technology-transfer activities to enable right-first-time execution.
• Design and deliver GMP training and coach colleagues to embed a sustained Right First Time culture.

Requirements

• Bachelor’s degree in a scientific or engineering discipline.
• Approximately 5 years of pharmaceutical QA experience in a GMP manufacturing environment.
• Must be based in or able to work on-site in Middletown, DE.
• Experience supporting greenfield site startups, new-facility start-ups, or NPI.
• Direct experience with sterile drug-product manufacturing and aseptic processing in a GMP setting.
• Strong knowledge of GMP regulations, ICH guidelines, and ALCOA+ data integrity principles.

Nice to have

• Quality or auditing certification (e.g., ASQ CQA, CQE, or CMQ/OE).
• Familiarity with risk-management tools (FMEA) and statistical process control concepts.
• Experience with electronic QMS or document-management platforms such as Veeva Vault and SAP.
• Familiarity with AI regulations and understanding of data-integrity risks associated with unvalidated AI tools.

Culture & Benefits

• Opportunity to work in a dynamic, build-stage environment contributing to a new facility.
• Focus on a Right First Time mindset and driving quality at the source.
• Collaborative environment partnering across manufacturing, engineering, and validation functions.
• Professional growth through establishing quality systems from the ground up.