GMP Documentation Specialist: Batch Records & Compliance

Augustbioservices; Nashville (TN); On-site; USD 60,000 - 80,000; Full time

Job summary

August Bioservices, headquartered in Nashville, TN, is seeking a Manufacturing Documentation Specialist to support GMP manufacturing through detailed batch record reviews and documentation control. You will ensure data integrity, compliance with FDA and ICH guidelines, and timely batch disposition.

You will collaborate with Manufacturing, Quality, and cross-functional teams, drive continuous improvement in GDP, and assist audits and regulatory inspections while maintaining rigorous documentation

Qualifications

• Bachelor of Science degree in Life Sciences or equivalent required.
• Minimum 2–3 years of experience in a regulated pharmaceutical/biotech manufacturing environment.
• Direct experience performing batch record review activities.
• Working knowledge of cGMPs and 21 CFR Parts 210, 211, 820; familiarity with PIC/S/EU GMP is a plus.
• Proficiency with electronic quality management systems (MasterControl or equivalent).
• Strong attention to detail and documentation accuracy; ability to resolve issues.

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.
• Create, revise, proofread, format, and merge GMP documentation (SOPs, batch records, logbooks).
• Support Manufacturing on the Floor with documentation review and GMP clarification.
• Ensure adherence to policies, procedures, and regulatory requirements including FDA, ICH, and global GMP standards.
• Support client audits and regulatory inspections by FDA and others; prepare and retrieve documentation.
• Communicate effectively with cross-functional teams to resolve documentation issues.

Skills

Detail oriented

Documentation control

Time management

Written communication

Independent work

Education

Bachelor of Science in Life Sciences

Tools

MasterControl

Job description

August Bioservices, headquartered in Nashville, TN, is seeking a Manufacturing Documentation Specialist to support GMP manufacturing through detailed batch record reviews and documentation control. You will ensure data integrity, compliance with FDA and ICH guidelines, and timely batch disposition.

You will collaborate with Manufacturing, Quality, and cross-functional teams, drive continuous improvement in GDP, and assist audits and regulatory inspections while maintaining rigorous documentation