QA Senior Shop Floor Manager
SHARP STERILE MANUFACTURING LLC•Lee, MA
•$90,000 - $130,000
About The Position
The Senior QA Shop Floor Manager serves as a senior quality leader responsible for shop floor QA oversight, batch disposition, and the site's aseptic process simulation (media fill) program. Reporting to the Director of Quality Operations, this role ensures real-time quality presence during manufacturing, drives timely and defensible batch disposition decisions, and owns the strategic and technical execution of the media fill program across all sterile product platforms.
Requirements
- Five (5) to ten (10) years’ experience working in a cGMP environment
- Five (5) years’ experience in a Quality role
- Three (3) to five (5) years’ experience supervising individuals in a cGMP environment
- Skilled in the use of Microsoft office applications (Word, Excel, PowerPoint) and Adobe Acrobat
- High attention to detail
- Good writing, public speaking and presentation skills
- Must be able to travel approximately 10% of the time
Responsibilities
- Provide direct oversight of real-time QA floor coverage during aseptic manufacturing operations, ensuring cGMP compliance, aseptic technique adherence, and immediate escalation of quality events
- Lead and develop a team of Specialists assigned to shop floor functions, fostering a proactive quality culture and high standard of GMP behavior
- Review and approve in-process documentation, logbooks, and batch record entries in real time; identify trends in errors or deviations and drive targeted corrective actions
- Serve as the quality authority (by way of the team) for line clearance, in-process controls, and manufacturing hold/release decisions during production, as needed
- Own the end-to-end batch disposition process, ensuring batch records are reviewed thoroughly, exceptions are appropriately investigated, and release or rejection decisions are made with scientific rigor and within defined cycle time targets
- Manage disposition timelines and communicate proactively with client-facing teams and Planning regarding batch status and any disposition risks
- Ensure batch disposition documentation meets regulatory and client quality agreement requirements across all product platforms and client accounts
- Track and trend disposition cycle times, batch record error rates, and right-first-time metrics; present findings and improvement plans to Quality leadership
- Serve as the site subject matter expert (SME) for aseptic process simulation, owning the strategy, design, execution oversight, and continuous improvement of the media fill program across all filling platforms and product types (liquid, lyophilized)
- Ensure media fill protocols reflect worst-case manufacturing conditions including maximum interventions, shift changes, line stoppages, and full fill durations; maintain alignment with FDA aseptic processing guidance and EU GMP Annex 1
- Lead media fill failure investigations (as needed) with appropriate scientific depth, including contamination pathway assessment, barrier performance evaluation, and robust CAPA with verified effectiveness
- Maintain media fill trending data and present program performance, risk assessments, and improvement initiatives to site and client quality leadership
- Serve as the primary point of contact for media fill topics during regulatory inspections and client audits; ensure inspection-ready documentation and clear, defensible storyboards
- Assist scheduling team with coordination of media fills to align with semi-annual requirement
- Partner with Manufacturing, Validation, Microbiology, and Sterility Assurance teams to ensure alignment on aseptic standards, process controls, and quality expectations
- Support client calls and technical quality meetings related to batch disposition status, media fill performance, and manufacturing deviations
- Contribute to audit readiness activities and represent shop floor quality and media fill topics during regulatory inspections and client audits
- Conduct business in a responsible manner that complies with all state, OSHA, and HIPAA regulations
- Maintain a detailed and comprehensive understanding of FDA, EU, and other regulatory agency requirements
- Manage quality activities at SSM
- Provide leadership to the GMP team related to Quality Culture
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What This Job Offers
Job Type
Full-time
Career Level
Senior
