Batch Records Compliance Specialist

INCOG BioPharma Services; Fishers (IN); On-site; USD 65,000 - 90,000; Full time

Job summary

INCOG BioPharma Services is seeking an Operations Batch Review Specialist to ensure post-execution batch documentation meets cGMP and SOP standards. You will collaborate with operations and quality systems to drive corrections and improvements, coaching teams for on-time batch release and compliant records.

The role emphasizes quality oversight, data integrity across systems, and proactive issue resolution in a fast-paced manufacturing environment.

Qualifications

• Knowledge of process control, quality engineering, sampling requirements, statistical techniques, and process capability.
• Familiarity with quality and regulatory requirements and trends and cGMPs.
• Strong communication skills and ability to build relationships across all levels.
• 4 years minimum experience in a GMP environment.
• Excellent written and verbal communication skills.
• General computer skills with SCADA; and data analysis software (Word, Excel, Visio, JMP, Minitab).

Responsibilities

• Full batch documentation review of parenteral manufacturing batch records for media fills and drug product.
• Identify corrections and deviations and elevate issues to Operations and Quality Supervisors.
• Provide training and feedback to Operators and Supervisors to improve on-the-floor batch record reviews.
• Support Quality Systems with timely completion of batch-impacting deviations to enable on-time batch release.
• Initiate deviations and participate in investigations to determine root cause and mitigation.
• Assist in authoring, reviewing and approving SOPs and work instructions.
• Prioritize record reviews within production timelines.
• Utilize systems (eDMS, SCADA, BMS, CMMS, LIMS, lab software) to ensure data integrity.
• Manage multiple projects in a fast-paced environment.
• Enforce SOPs, quality guidelines, and site compliance.

Skills

Quality engineering

Statistical techniques

Process capability

Strong communication

Cross-functional collaboration

Documentation

Tools

SCADA

Word

Excel

Visio

JMP

Minitab

LIMS

CMMS

Job description

INCOG BioPharma Services is seeking an Operations Batch Review Specialist to ensure post-execution batch documentation meets cGMP and SOP standards. You will collaborate with operations and quality systems to drive corrections and improvements, coaching teams for on-time batch release and compliant records.

The role emphasizes quality oversight, data integrity across systems, and proactive issue resolution in a fast-paced manufacturing environment.