QA Batch Release & Quality Compliance Specialist

INCOG BioPharma Services; Fishers (IN); Presencial; USD 65.000 - 90.000; Jornada completa

Descripción de la vacante

INCOG BioPharma Services in Fishers, Indiana seeks a QA Specialist - Batch Review to ensure timely release of parenteral products. You’ll review batch records, support QA systems, and collaborate with cross-functional teams to drive quality and efficiency.

The role emphasizes adherence to GMP, data integrity, and continuous improvement, with exposure to regulatory interactions and client-facing activities. On-site in Fishers, IN.

Responsabilidades

• Perform full lifecycle review and disposition of parenteral manufacturing batch records for formulation, filling, inspection, and packaging activities for media fills and drug product.
• Provide client access and support during batch record review and approval processes.
• Support timely batch release activities by partnering with Quality Systems and Operations.
• Create and report batch release metrics to site leadership.
• Advise and approve batch record Bills of Materials (BOMs) and Engineering Change Orders (ECOs).
• Support investigations into manufacturing and quality events, including root cause determination and mitigation planning.
• Participate in investigations involving major and critical deviations.
• Conduct preliminary evaluations of deviating events to determine impact, product segregation requirements, and immediate corrective actions.
• Escalate significant issues to management when appropriate.
• Support deviation investigations through root cause analysis, risk assessments, report writing, and mitigation development.
• Review plant automation alarms and support quality oversight activities.
• Author, review, and approve SOPs, work instructions, and related GMP documentation.
• Train QA Associates and Specialists on surveillance oversight and on-the-floor batch record review requirements.
• Support quality initiatives aimed at improving operational efficiency, compliance, and product quality.
• Analyze site trends using technical and statistical tools to identify sources of variability and process improvement opportunities.
• Promote a strong quality mindset and culture of continuous improvement.
• Utilize electronic and paper-based quality systems, including: eDMS, SCADA, BMS, CMMS, LIMS, Laboratory Instrument Software.
• Ensure data integrity and compliance with site procedures, quality standards, and regulatory requirements.
• Balance production schedules with quality and compliance requirements.
• Collaborate effectively with Operations, Quality Control, Engineering, Validation, and client teams.
• Influence positive outcomes through strong partnerships and technical expertise, regardless of reporting structure.
• Manage multiple priorities and projects in a fast-paced manufacturing environment.
• Demonstrate a proactive commitment to safety.
• Practice positive intervention and enforce compliance with SOPs, quality requirements, and site expectations.
• Support a culture focused on operational excellence, teamwork, and customer success.

Descripción del empleo

INCOG BioPharma Services in Fishers, Indiana seeks a QA Specialist - Batch Review to ensure timely release of parenteral products. You’ll review batch records, support QA systems, and collaborate with cross-functional teams to drive quality and efficiency.

The role emphasizes adherence to GMP, data integrity, and continuous improvement, with exposure to regulatory interactions and client-facing activities. On-site in Fishers, IN.