The Manufacturing Documentation Specialist supports GMP manufacturing by performing detailed review of batch production records and driving corrections. This role plays a critical part in ensuring accurate, compliant, and timely batch 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 supports record release, continuous improvement and inspection readiness 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.