QUALITY OPERATIONS MANAGER (SHOP FLOOR)

Job Purpose: 

• Provide real-time QA oversight across BFS and aseptic manufacturing to ensure compliant, accurate, and efficient execution of GMP production activities.
• Ensure full adherence to FDA, cGMP, and internal Quality System requirements through on-floor presence, documentation oversight, and cross functional coordination.
• Lead, develop, and support the Quality Operations team, promoting a strong culture of compliance, ownership, and right-first-time performance.
• Drive operational and quality excellence through proactive issue identification, timely decision-making, and effective cross functional partnerships.
• Support continuous improvement initiatives to strengthen documentation practices, reduce deviations, and enhance audit readiness.
• Oversee and support Visual Inspection operations  

Essential Duties and Responsibilities:

• Provide daily oversight of BFS and aseptic operations, including observation of critical process steps, cleanroom behaviors, and adherence to established parameters.
• Ensure batch execution aligns with cGMPs, SOPs, and documentation standards; review in-process documentation for accuracy, completeness, and right the first time expectations.
• Maintain a high state of inspection readiness for regulatory, state, and customer audits through routine walkthroughs, documentation checks, and reinforcement of quality behaviors.
• Provide QA oversight of Facilities and Engineering work performed in or impacting GMP areas, including documentation verification and approvals in validated electronic systems.
• Support deviation investigations, including documentation of events, fact gathering, root cause analysis, and CAPA implementation.
• Ensure timely and accurate review of batch records, logbooks, and supporting documentation; identify trends and error patterns for corrective action.
• Collaborate with respective departments to resolve realtime issues and support continuous improvement of processes, documentation, and material flow.
• Provide coaching, mentoring, and training for QA and Production personnel regarding documentation accuracy, procedural compliance, and GMP expectations.
• Develop, monitor, and report key quality metrics such as right the first time, documentation errors, and operational compliance trends.
• Promote contamination control, aseptic discipline, and strong adherence to cleanroom requirements across all shop floor operations.
• Communicate quality issues and significant observations promptly to Quality leadership to support timely decision-making and escalation when required.
• Ensure visual inspectors are properly trained and qualified for operations. 
• Verify adherence to approved inspection procedures and support development and maintenance of work instructions and defect libraries. 
• Perform any other duties related to the Quality Assurance function as necessary or assigned.

Job Specifications and Qualifications: 

Knowledge & Skills: 

• Strong understanding of cGMPs, FDA regulations, Quality Systems, and documentation requirements supporting sterile manufacturing.
• Knowledge of sterility assurance concepts, cleanroom behavior, and contamination control within aseptic or BFS environments.
• Experience reviewing batch records, assessing documentation accuracy, and supporting deviation and CAPA processes.
• Ability to lead, coach, motivate, and develop Quality Operations personnel.
• Strong analytical, problem-solving, and root cause analysis skills.
• Effective communication, technical writing, and cross-functional collaboration capabilities.
• Proficiency with Microsoft Word, Excel, PowerPoint, and electronic Quality Systems.
• Strong attention to detail, time management, and organizational skills.

Education/Experience: 

• Bachelor of Science degree preferred.
• 5+ years of Quality Assurance experience in sterile pharmaceutical manufacturing preferred.
• 3+ years of supervisory or management experience in a GMP environment preferred.
• Experience supporting regulatory inspections and interacting with auditors.
• Familiarity with BFS or aseptic production environments strongly preferred.

Working Conditions / Physical Requirements:

• Requires routine walking through production areas, standing, bending, typing, and lifting up to 40 lbs.
• Requires gowning and work within cleanroom environments.

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