The QA Operations Specialist II – Floor Support

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Date Issued:

August 18, 2026

Application Deadline:

August 25, 2026

Wage Level:

Salary

JOB DESCRIPTION:Position Title: QA Specialist II – Ops/Floor Support

Location: Bedford, New Hampshire

Department: Quality Assurance Operations

Reporting To: QA Supervisor or above

Responsible For (Staff): Yes

The QA Operations Specialist II – Floor Support is responsible for providing QA support of Manufacturing and Visual Inspection activities for clinical and commercial drug product in a GMP facility. The work scope includes on-the-floor Quality oversight of manufacturing activities including observing formulation and aseptic processes, performing AQL visual inspection of finished drug product vials, GMP documentation and Batch Record review, line clear and product changeover activities, disposition of incoming raw materials, review and approval of facility work orders, and other various QA functions as needed. Real time continuous monitoring of manufacturing related systems and processes to ensure compliance with applicable regulatory and industry standards, quality improvements, and safety/efficacy for phase appropriate GMP manufacture of drug products.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Perform QA on-the-floor activities supporting client projects, including room release, auditing critical processes, reviewing GMP documentation in real time, and resolving issues that occur during manufacturing.
• Consult with internal teams such as Operations, QC, Facilities/Engineering, Project Management, and Materials Management to resolve complex situations or problems.
• Perform frequent walkthroughs and internal audits of manufacturing and support areas to ensure adherence to policies and procedures. May include management from groups such as Operations, Facilities, Quality, and Materials Management.
• Batch record review for adherence to internal procedures and Good Documentation Practices
• Support the evaluation and disposition of intermediates, finish bulk drug substance and drug product.
• Review, approval and disposition of incoming materials such as consumables, excipients, and Active Pharmaceutical Ingredient.
• QA review and approval of new and revised GMP documents such as SOP’s and raw material specifications.