Manufacturing Documentation Specialist

Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry.

Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow. To support our growth plans, August is investing significant capital in a two-phase expansion project – including building a new state-of-the-art facility adjacent to our current facility. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August!

The Manufacturing Documentation Specialist supportsGMP manufacturingby performing detailed review of batch production records and driving corrections.

This role plays a critical part in ensuring accurate, compliant, andtimelybatch record review activities in support of batch disposition and release.

The Manufacturing Documentation Specialist collaborates closely with Manufacturing, Quality, and other cross-functional teams to ensure documentation accuracy, data integrity, and compliance with current Good Manufacturing Practices (cGMP) and applicable regulatory requirements. This position also supportsrecord release, continuousimprovementandinspectionreadiness activities within a fast-paced, regulated manufacturing environment.

• 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, including SOPs, batch records, and logbooks in support of site operations.
• Support Manufacturing on the Floor by assisting with documentation review, clarification of GMP requirements, and real-time support.
• Ensure adherence to company policies, procedures, and applicable regulatory requirements, including FDA, ICH, and global GMP standards.
• Support client audits and regulatory inspections by FDA and other regulatory agencies, including preparation and retrieval of documentation.
• Communicate effectively with cross-functional teams to resolve documentation issues and support timely completion of quality activities.

• Bachelor of Science degree in Life Sciences, or a related discipline required, or an equivalent combination of education and relevant experience.
• Minimum of two (2) to three (3) years of experience working in a regulated pharmaceutical, biotechnology, or medical device manufacturing environment required.
• Minimum of two (2) years of direct experience performing batch record review activities required.
• Working knowledge of cGMP requirements, including 21 CFR Parts 210, 211, 820, and familiarity with PIC/S Guide to Good Manufacturing Practice Parts I and II or EU GMP guidelines, including Annex 1.
• Knowledge of FDA Guidance on Aseptic Processing and 21 CFR Part 11 electronic records and signatures requirements preferred.
• Proficiency in electronic quality management systems, including Master Control or equivalent platforms.
• Strong attention to detail and documentation accuracy, with the ability to identify errors, inconsistencies, and compliance gaps.
• Excellent organizational and time management skills, with the ability to prioritize multiple tasks in a fast-paced environment.
• Strong written and verbal communication skills, with the ability to communicate clearly and professionally with cross-functional teams.
• Ability to work independently while maintaining accountability to quality standards, timelines, and procedures.
• Demonstrated commitment to data integrity, compliance, and continuous improvement.

• Ability to perform all required gowning.
• Ability to work in an office and manufacturing environment, including time spent on the…