Product Quality Assurance Supervisor
The Supervisor serves as the primary Quality representative supporting manufacturing operations across all production shifts while driving consistent execution of QAOTF activities.
ESSENTIAL DUTIES & RESPONSIBILITIES
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Directly supervise the AQL and Quality on the Floor teams.
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Provide coaching, mentoring, performance management, and employee development.
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Manage staffing, scheduling, workload balancing, and shift coverage to support manufacturing operations, including evenings and weekends.
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Conduct performance evaluations and establish development plans.
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Ensure effective QA presence during manufacturing operations.
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Provide real-time GMP oversight of production activities.
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Ensure manufacturing follows approved batch records, SOPs, and GMP requirements.
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Escalate quality concerns to QA Management as appropriate.
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Manage the Quality Assurance AQL and visual inspection program.
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Ensure inspection activities are performed in accordance with approved procedures.
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Maintain AQL visual inspection qualification programs.
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Partner with Manufacturing to establish inspection standards and qualification requirements.
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Monitor inspection trends and recommend process improvements.
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Partner with Manufacturing leadership to coordinate QAOTF support.
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Ensure appropriate QA coverage for production schedules.
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Support and review investigations, deviations, CAPAs, and change controls impacting manufacturing operations.
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Support batch record review and batch disposition/release activities.
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Participate in production meetings and provide Quality input.
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Ensure compliance with FDA, EMA, ICH, and company procedures.
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Identify compliance risks and implement corrective actions.
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Assist with internal audits, client audits, and regulatory inspections.
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Track and report department metrics including inspection effectiveness, QA observations, and compliance trends.
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Recommend improvements to QAOTF processes and inspection programs.
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Communicate quality issues promptly to the Product QA Manager.
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Build collaborative relationships across Manufacturing, QC, Validation, Engineering, and Supply Chain.
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Promote a quality-focused culture throughout manufacturing operations.
KNOWLEDGE, SKILLS, & ABILITIES
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GMP compliance knowledge including knowledge of 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1 and FDA Guidance on Aseptic Processing and Part 11 compliance knowledge preferred.
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Root Cause Analysis Tools, Risk Management, Technical Writing, Microsoft Office applications, eQMS and LIMS systems
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Experience with visual inspection, AQL programs, deviations, CAPAs, and manufacturing support activities.
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Strong communication, leadership, and organizational skills.