GMP Documentation Specialist — Batch Review & Compliance

August Bioservices

Nashville (TN)

On-site

USD 65,000 - 95,000

Full time

14 days+

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Job summary

August Bioservices in Nashville, TN, is seeking a Manufacturing Documentation Specialist to ensure accurate, compliant batch record review and documentation control in a fast-paced GMP environment. You will collaborate with Manufacturing, Quality, and cross-functional teams to support batch disposition, FDA inspections, and continual improvement while maintaining data integrity.

The role requires a Life Sciences degree and 2–3 years in regulated pharma manufacturing with direct batch record

Qualifications

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

Responsibilities

Review executed batch production records to support 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.
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 GMP requirements.
Ensure adherence to FDA, ICH, and global GMP standards.
Support client audits and regulatory inspections by FDA and others, including documentation retrieval.
Communicate effectively with cross-functional teams to resolve documentation issues.