Batch Documentation & Compliance Specialist

INCOG BioPharma Services; Fishers (IN); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Paid vacation and sick time

11 holidays

401(k) plan with company match up to 3

Health & wellness plans

FSA and HSA

Dental & vision care

Job summary

INCOG BioPharma Services in Fishers, IN is seeking an Operations Batch Review Specialist to ensure batch records comply with cGMP and SOPs. You will review parenteral manufacturing documents and coach operators to improve on-the-floor batch record reviews.

You will work with Operations and Quality Systems to drive timely deviations investigations, CAPA implementation, and data integrity across systems like SCADA, LIMS, and CMMS.

Qualifications

• 4 years minimum experience in a GMP environment.
• Review batch documentation for parenteral manufacturing.
• Identify corrections and deviations and escalate.
• Provide training to Operators and Supervisors on batch reviews.
• Support CAPA and quality systems related to deviations.

Responsibilities

• Lead full batch documentation review for parenteral manufacturing Batch Records.
• Identify corrections, deviations and escalate found issues.
• Provide training and feedback to Operators and Supervisors on batch reviews.
• Support Quality Systems with timely completion of batch impacting deviations.

Skills

Process control

Quality engineering

Sampling requirements

Statistical techniques

Process capability

GMP experience

Communication skills

Data analysis

Tools

SCADA

Word

Excel

Visio

JMP

Minitab

Job description

INCOG BioPharma Services in Fishers, IN is seeking an Operations Batch Review Specialist to ensure batch records comply with cGMP and SOPs. You will review parenteral manufacturing documents and coach operators to improve on-the-floor batch record reviews.

You will work with Operations and Quality Systems to drive timely deviations investigations, CAPA implementation, and data integrity across systems like SCADA, LIMS, and CMMS.