Quality Assurance Specialist - Pharmaceuticals

TL;DR

Quality Assurance Specialist - Pharmaceuticals (GMP/sterile manufacturing): Building and implementing quality systems for a new pharmaceutical manufacturing facility with an accent on on-floor QA support, aseptic processing, and QMS development. Focus on leading deviations, CAPAs, change controls, validation readiness, and inspection preparation while establishing right-first-time operations.

Location: On-site in Middletown, Delaware, United States

Company

hirify.global is establishing new pharmaceutical manufacturing capabilities and the quality systems needed to support OSD and sterile drug-product operations.

What you will do

• Provide real-time quality assurance support on the manufacturing floor, including batch-record review and quality-event disposition.
• Establish the site QMS and author SOPs, work instructions, and job aids for sterile, aseptic, and drug-product operations.
• Own deviations, investigations, root-cause analysis, CAPAs, change controls, and effectiveness checks.
• Review commissioning, qualification, validation, and process-validation documentation, including URS, FAT/SAT, IQ/OQ/PQ, and turnover packages.
• Lead readiness inspections, support NPI and technology transfer, and advise internal, client, and regulatory stakeholders.
• Deliver GMP training and coach manufacturing, engineering, validation, and quality colleagues during site start-up.

Requirements

• Bachelor’s degree in a scientific or engineering discipline, or equivalent relevant experience.
• Approximately five years of pharmaceutical or biopharmaceutical QA experience, including hands-on GMP manufacturing experience.
• Experience with greenfield site start-up, new-facility QMS implementation, or NPI in a multiproduct pharmaceutical manufacturing environment.
• Direct experience with sterile drug-product manufacturing and aseptic processing.
• Working knowledge of GMP regulations, ICH guidelines, Good Documentation Practices, ALCOA+, risk management, and statistical process control.
• Experience with electronic QMS or document-management systems such as Veeva Vault and SAP, audits and inspections, and cross-functional stakeholder management.

Nice to have

• Quality or auditing certification such as ASQ CQA, CQE, or CMQ/OE.
• Familiarity with AI regulations and the data-integrity and confidentiality risks of unvalidated AI tools.

Culture & Benefits

• Work in a dynamic, build-stage environment with limited precedent and evolving quality systems.
• GMP manufacturing work includes cleanrooms, classified areas, gowning, aseptic behaviors, and regular on-floor presence.
• Requires periods of standing and walking during production operations.
• Occasional travel for audits.
• Emphasis on right-first-time execution, structured problem-solving, collaboration, and coaching.