Manufacturing Documentation Specialist

ESSENTIAL DUTIES & 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, including SOPs, batch records,and  logbooksin 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 auditsand 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.

QUALIFICATIONS

• 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.

KNOWLEDGE, SKILLS, & ABILITIES

• 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 MasterControl 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.

PHYSICAL REQUIREMENTS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ability to perform all required gowning.

• Ability to work in an office and manufacturing environment, including time spent on the production floor as needed.

• Ability to sit or stand for extended periods while reviewing documentation and working at a computer.

• Ability to use standard office equipment, including computers, printers, and scanners.

• Ability to lift and carry materials or files up to 20 pounds, with or without reasonable accommodation.

• Ability to wear required personal protective equipment (PPE) when supporting activities in manufacturing areas.