Aseptic Manufacturing Quality Assurance Technician

Job Description

Job Description

A day in the life

Picture this: it’s 2:00 PM and you’re stepping onto the production floor at 7405 Page Ave, St. Louis, MO. You’re the quality partner the team relies on—keeping operations aligned to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, and EU MDR. You move from an in-process check at a sub-assembly station to a line-stop investigation, capturing facts, testing product, and documenting every step with precision. By evening, you’re reviewing DHRs, supporting batch release decisions, and confirming that calculations, dose ranges, dosimeter placements, and any special instructions are correct before final product release.

Along the way, you’ll help drive corrective actions, serve on the Material Review Board, maintain site calibration records, perform environmental monitoring, and keep quality data current in local and global systems. Your work strengthens our aseptic operations and ensures safe, compliant outcomes.

• Lead or support production line quality investigations; document findings and corrective actions.
• Coordinate and perform in-process and final quality acceptance testing (as applicable to the facility).
• Identify and document product and process nonconformances; participate on the Material Review Board.
• Review Device History Records (DHRs) and support batch record release activities.
• Enter, retrieve, and analyze quality data across site, local, and global systems.
• Execute and document site calibration and environmental monitoring programs.
• Verify calculations, dose ranges, dosimeter placement, and special instructions before processing and at final release.

• Shift: 2:00 PM – 10:30 PM (2nd shift) + overtime as needed
• Pay: $20.43 – $25/hour + bonus
• Location: 7405 Page Ave, St. Louis, MO

• High School Diploma and 3+ years in manufacturing/repair/technical production; or Associate’s Degree and 1+ year in manufacturing or repair.
• Comfort with math such as ratios, proportions, and basic algebra.
• Ability to thrive in a fast-paced, deadline-driven setting and to:
  • Read and follow written instructions, safety labels, and equipment manuals.
  • Create accurate, detailed documentation.
  • Collaborate to analyze and solve technical problems.
  • Partner professionally across teams; work with minimal supervision.
  • Use basic computer applications, including Excel and Word.
  • Cross-train within the aseptic department.
• May be expected to move, carry, and lift ~50 pounds.

• Experience in regulated environments (ISO 13485 and FDA specifically).
• Aseptic gowning experience.
• Good Documentation Practices (GDP).
• Experience in chemical manufacturing.

• Bending, walking, standing, sitting, typing, hand use, and visual acuity.
• Ability to lift, push, and pull 25–50 lbs as needed.

• Hazardous Materials
• Lean Manufacturing Principles
• Good Manufacturing Practices (GMP)
• Experience in a Manufacturing Environment
• Aseptic
• Aseptic Gowning
• ISO 9001
• Oracle System Experience

We’re committed to your health, well-being, and financial future.

• Market competitive pay
• Extensive Paid Time Off plus 9 additional holidays
• Excellent medical, dental, and vision coverage
• Short- and long-term disability
• 401(k) with company match
• Maternity and paternal leave
• Optional add-ons and discounts (e.g., Pet Insurance)
• Tuition reimbursement and continuing education
• Strong advancement paths and long-term stability

Join a team where quality is the foundation of everything we build—and every patient we protect.