GMP Documentation & Training Coordinator - Biotech

Union Agener, Inc.; Augusta (GA); On-site; USD 60,000 - 85,000; Full time

Benefits offered by this job

401(k) Plan + Company Match

Vacation and Company Holidays

Career Progression

Job summary

Union Agener, Inc. is seeking a skilled Documentation Coordinator to support manufacturing operations in Augusta, GA. The role focuses on batch record disposition, SOP updates, training, and cross-training of API operations, ensuring compliance and quality across production teams.

The successful candidate will bring strong technical writing, SAP/Excel proficiency, and experience with process trending, enabling effective documentation and onboarding within a GMP setting.

Qualifications

• High School Diploma or GED required.
• Good technical writing and communication skills.
• Team player with strong organizational and problem-solving abilities.
• Proficient in SAP, Word and Excel.
• Experience with process trending (Aspen) is a plus.

Responsibilities

• Review and disposition batch records.
• Execute all duties according to applicable Safety and Quality SOPs.
• Update standard operating procedures and entry isolation plans for plant equipment as required.
• Modify procedure to maintain practice vs. procedure.
• Provide onboarding services to new hires.
• Assist in facilitating leader-led training in production.
• Review and maintain area logbooks.
• Partner with production leaders to ensure training and cross-training of operations staff in API.
• Develop and facilitate employee qualification plans and partner with production leaders to ensure employees remain in qualified status.
• Create and update training modules in partnership with other functions and provide support for large scale site training improvements.
• Identify, analyze, and recommend solutions regarding performance gaps.
• Participate regularly in area process teams.
• Participate on Project Teams; may lead small projects related to training or other production activities.
• (5S, housekeeping, safety, etc.)
• Champion the implementation of programs and projects within the process operations area
• Backfill behind shift roles on days to relieve shift individuals so they may participate in teams/committees or complete other tasks
• Cover emergency call outs for sick time and emergency vacation under the direction of the shift supervisors

Skills

Technical writing

Communication skills

Team player

Organizational skills

Problem solving

SAP

Excel

Word

Aspen

Process trending

Education

High School Diploma or GED

Tools

SAP

Excel

Word

Aspen

Job description

Union Agener, Inc. is seeking a skilled Documentation Coordinator to support manufacturing operations in Augusta, GA. The role focuses on batch record disposition, SOP updates, training, and cross-training of API operations, ensuring compliance and quality across production teams.

The successful candidate will bring strong technical writing, SAP/Excel proficiency, and experience with process trending, enabling effective documentation and onboarding within a GMP setting.