GMP Documentation & Batch Review Specialist

August-Bioservices; Nashville (TN); On-site; USD 60,000 - 90,000; Full time

Job summary

August Bioservices, headquartered in Nashville, TN, seeks a Manufacturing Documentation Specialist to ensure accurate, compliant batch record review supporting disposition and release. You will collaborate with Manufacturing, Quality, and other teams to maintain data integrity and regulatory compliance in a fast-paced environment.

The role emphasizes cGMP adherence, documentation accuracy, and readiness for inspections, with opportunities to contribute to continuous improvement and on-floor

Qualifications

• Bachelor of Science in Life Sciences or related field required.
• 2–3 years of experience in a regulated pharmaceutical/biotech/manufacturing environment.
• Minimum 2 years direct experience performing batch record review.

Responsibilities

• Review executed batch production records to support batch disposition and release activities.
• Identify and drive continuous improvements to GDP through record enhancements.
• Track GDP performance and record release timing through sitewide metrics.
• Participate in on-the-floor real-time review and collaboration with cross-functional teams.
• Create, revise, proofread, format, and merge GMP documentation including SOPs, batch records, and logbooks.
• Support Manufacturing on the Floor by assisting with documentation review and clarification of GMP requirements.

Skills

cGMP knowledge

Batch record review

Documentation control

Cross-functional collaboration

Education

Bachelor of Science in Life Sciences

Tools

MasterControl or equivalent

Job description

August Bioservices, headquartered in Nashville, TN, seeks a Manufacturing Documentation Specialist to ensure accurate, compliant batch record review supporting disposition and release. You will collaborate with Manufacturing, Quality, and other teams to maintain data integrity and regulatory compliance in a fast-paced environment.

The role emphasizes cGMP adherence, documentation accuracy, and readiness for inspections, with opportunities to contribute to continuous improvement and on-floor