GMP Quality Batch Release Specialist

Jobvite, Inc.; Fishers (IN); On-site; USD 65,000 - 95,000; Full time

Job summary

INCOG BioPharma Services in Fishers, IN seeks a QA Specialist - Batch Review to review and disposition parenteral batch records, supporting quality systems and timely product release. You will collaborate with QA, Operations, and client teams in a fast-paced GMP environment.

The role emphasizes investigations, data integrity, and using statistical tools to drive process improvements while ensuring strict regulatory compliance and on-time delivery.

Qualifications

• Bachelor's degree in chemistry, biology, biochemistry, microbiology, or related field.

Responsibilities

• Perform full lifecycle review and disposition of parenteral batch records from formulation to packaging.
• 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 BOMs and Engineering Change Orders (ECOs).
• Support investigations into manufacturing and quality events, including root cause analysis.
• Participate in investigations involving major and critical deviations.
• Conduct preliminary evaluations of deviating events to determine impact and corrective actions.
• Escalate significant issues to management.
• Review plant automation alarms and support quality oversight activities.
• Author, review, and approve SOPs and related GMP documentation.
• Train QA Associates on batch record review requirements.
• Analyze site trends using statistical tools to identify variability and process improvements.
• Promote a strong quality mindset and continuous improvement culture.

Skills

Communication

Organization

Time management

Independent work

Cross-functional collaboration

Microsoft Office

SCADA

Data analysis tools

Education

Bachelor's degree in Chemistry/Biology/Biochemistry/Microbiology or related field

Tools

SCADA

LIMS

eDMS

BMS

CMMS

Laboratory Instrument Software

Excel

Visio

JMP

Minitab

Job description

INCOG BioPharma Services in Fishers, IN seeks a QA Specialist - Batch Review to review and disposition parenteral batch records, supporting quality systems and timely product release. You will collaborate with QA, Operations, and client teams in a fast-paced GMP environment.

The role emphasizes investigations, data integrity, and using statistical tools to drive process improvements while ensuring strict regulatory compliance and on-time delivery.