GMP Technical Writing Specialist — Hybrid Contract

Creative Solutions Services, LLC

New Albany (OH)

Hybrid

USD 45,000 - 51,000

Part time

5 days ago
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Benefits offered by this job

Medical, Vision, and Dental Insurance
401k Retirement Fund

Job summary

Creative Solutions Services, LLC in New Albany, OH seeks a Specialist Technical Writer to draft and revise SOPs, protocols, technical reports, and training materials in a GMP-regulated environment that supports manufacturing.

You will collaborate with manufacturing and quality teams to ensure accurate documentation, manage change controls, CAPA, deviations, and timely document turnaround for compliance.

Qualifications

  • GMP background in a manufacturing or biotech setting.
  • Experience owning deviations and CAPA investigations.
  • Strong written and oral communication skills.

Responsibilities

  • Develop, review, and update GMP documentation for the manufacturing team.
  • Provide technical and clerical support for documentation and data tracking.
  • Coordinate with cross-functional teams to implement documentation changes.
  • Support change controls, deviations, CAPA, and investigations with SMEs.
  • Ensure timely completion of document-related actions and current schedule upkeep.

Skills

GMP background
Deviation ownership
Communication skills

Education

Master's Degree in Science/Engineering
Bachelor's Degree in Science/Engineering + 2 years Manufacturing/Quality
Associate's Degree in Science/Engineering + 5 years Manufacturing/Quality
High School Diploma/GED + 8 years Manufacturing/Quality

Job description

Creative Solutions Services, LLC in New Albany, OH seeks a Specialist Technical Writer to draft and revise SOPs, protocols, technical reports, and training materials in a GMP-regulated environment that supports manufacturing.

You will collaborate with manufacturing and quality teams to ensure accurate documentation, manage change controls, CAPA, deviations, and timely document turnaround for compliance.

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