Sobre esta vaga de Product Quality Assurance Supervisor na August Bioservices
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.
