Quality Assurance Specialist, On the floor (Overnights)

About the role

This position supports Quality Assurance (QA) initiatives for a broad range of topics relative to the start-up and operations of a drug product facility. It offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Responsibilities

• Work on and potentially lead efforts to establish new programs including start-up of formulation, filling, inspection, assembly, and pack and label teams
• Perform assessments of existing procedures/documents to gauge appropriateness for the inclusion of drug product operations; where current documents are not adequate, identify path forward for establishment of procedures
• Develop, write, review, and approve SOPs, specifications, and other documents (e.g., operation and facility SOPs, quality training, batch documentation)
• Maintain project timelines to support the evolving business
• Perform on-the-floor quality review of documents, such as: equipment logs, training records, testing results, batch records, and supporting documents
• Review and approval of documents (electronic and paper-based)
• Provide mentorship during on-the-floor manufacturing
• Support audits, inspections, and investigations
• Perform quarantine, segregation of material, and line clearances
• Contribute to continuous improvement initiatives
• Adjust schedule based on facility start-up, filling, and manufacturing needs
• Collaborate with cross-functional internal teams

Work Environment

• Gowning: full cleanroom attire (e.g., laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves, and use of sanitizing agents like IPA during gowning)
• Ability to remove jewelry, make-up, and nail adornments when wearing cleanroom attire
• Ability to perform physical requirements for entirety of shift (up to 10 hours) in a cleanroom environment, including:
  • Bending, climbing, crawling, kneeling, reaching, reaching overhead
  • Sitting, squatting, walking, standing, driving
  • Hand manipulation and ability to lift/push/pull up to 50 lbs

Requirements

• B.S. in life sciences or related field; proven experience may substitute for education
• Associate QA Specialist: 2+ years of experience
• QA Specialist: 4+ years of experience
• Level determined based on experience

Schedule

• 3rd shift, Friday–Tuesday, 10:00 PM–8:30 AM
• 3rd shift, Monday–Friday, 10:00 PM–8:30 AM

Benefits

• Student loan paydown program & tuition reimbursement
• Family care benefits
• Relocation assistance
• Inclusion, culture, and well-being programs (including physical & mental health)
• Competitive and comprehensive total rewards package, which may include:
  • Annual bonuses or other incentive plans
  • Equity awards
  • Pension or retirement benefits, 401(k) company match
  • Health and wellness programs, fitness centers
  • Insurance benefits (e.g., medical, dental, vision, life, and disability)
  • Paid time off
  • Family support benefits

Pay

Salary Range (annually): $62,355.00 – $110,000.00

Location: East Greenbush, New York, United States