GMP Documentation Specialist - Batch Records & Compliance

Ring Inc; Nashville (TN); On-site; USD 70,000 - 90,000; Full time

Job summary

August Bioservices, headquartered in Nashville, TN, seeks a Manufacturing Documentation Specialist to support GMP manufacturing by reviewing batch production records and driving corrections. The role collaborates across Manufacturing, Quality, and other teams to ensure data integrity and regulatory compliance in a fast-paced setting.

The ideal candidate has a Life Sciences degree and 2–3 years in a regulated pharma environment, with hands-on experience in batch record review and GMP

Qualifications

• Bachelor degree in Life Sciences or related field.
• Minimum 2–3 years in regulated pharmaceutical manufacturing environment.
• Direct experience performing batch record review.

Responsibilities

• Review executed batch production records to support batch disposition and release.
• Identify and drive continuous improvements to GDP through record enhancements.
• Track GDP performance and release timing via sitewide metrics.
• Participate in on-the-floor real-time review.
• Create, revise, proofread, format, and merge GMP documentation (SOPs, batch records, logbooks).
• Support Manufacturing on the Floor with documentation review and GMP guidance.
• Ensure adherence to policies and regulatory requirements (FDA, ICH, GMP).
• Assist with client audits and regulatory inspections; prepare and retrieve documentation.
• Communicate with cross-functional teams to resolve documentation issues.

Skills

cGMP knowledge

Batch record review

Documentation accuracy

Data integrity

Cross-functional communication

Education

Bachelor of Science in Life Sciences

Tools

MasterControl

Job description

August Bioservices, headquartered in Nashville, TN, seeks a Manufacturing Documentation Specialist to support GMP manufacturing by reviewing batch production records and driving corrections. The role collaborates across Manufacturing, Quality, and other teams to ensure data integrity and regulatory compliance in a fast-paced setting.

The ideal candidate has a Life Sciences degree and 2–3 years in a regulated pharma environment, with hands-on experience in batch record review and GMP