Biotech Documentation Coordinator - Training & Compliance

Union-Agener

Augusta (GA)

On-site

USD 55,000 - 75,000

Full time

5 days ago
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Benefits offered by this job

Competitive Benefits Package and EAP
401(k) Plan + Company Match
Vacation + End of Year Vacation (Co. S

Job summary

Union Agener seeks a Documentation Coordinator with manufacturing experience to review batch records and ensure compliance with Safety and Quality SOPs. The role involves updating procedures, onboarding new hires, and supporting production training.

Candidates should have strong technical writing, communication, and organizational skills, plus proficiency in SAP, Word and Excel. Collaboration with production leaders is essential for cross-training and investigations.

Qualifications

  • Good technical writing skills.
  • Excellent verbal and written communication.
  • Experience in a manufacturing environment preferred.
  • Proficient with SAP, Word and Excel.
  • Process trending experience with Aspen is a plus.
  • Knowledge of API process areas is beneficial.

Responsibilities

  • Review and disposition batch records.
  • Follow Safety and Quality SOPs.
  • Update SOPs and entry isolation plans for plant equipment.
  • Provide onboarding services to new hires.
  • Assist in facilitating leader-led training in production.
  • Maintain area logbooks and train staff in API operations.
  • Develop training modules with other functions.

Skills

Technical writing
Communication
Team player
Organizational skills
Problem solving
Training coordination

Education

High School Diploma or GED

Tools

SAP
Aspen
MS Word
MS Excel

Job description

Union Agener seeks a Documentation Coordinator with manufacturing experience to review batch records and ensure compliance with Safety and Quality SOPs. The role involves updating procedures, onboarding new hires, and supporting production training.

Candidates should have strong technical writing, communication, and organizational skills, plus proficiency in SAP, Word and Excel. Collaboration with production leaders is essential for cross-training and investigations.

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