GMP Technical Documentation Specialist

Merck & Co.; New Albany (OH); Hybrid; USD 70,000 - 100,000; Full time

Job summary

Merck & Co. seeks a documentation specialist to support manufacturing by drafting and revising GMP documents such as SOPs, protocols, and training materials. You will collaborate with cross-functional teams to ensure accurate, up-to-date records and assist in CAPA and deviation processes.

Ideal candidates hold a science/engineering degree with 2+ years in manufacturing, packaging, or quality within pharma/biotech. Onsite with occasional WFH after 6 months, standard hours 8-5.

Qualifications

• Experience drafting and revising GMP documentation (SOPs, protocols, reports).
• Ability to translate technical content for manufacturing operators.
• Background in deviations, CAPA, and change controls.

Responsibilities

• Draft and revise SOPs, protocols, technical reports, and training materials in GMP environment.
• Develop and update technical content for manufacturing processes.
• Support documentation preparation and data tracking for the manufacturing team.
• Liaise with cross-functional teams on documentation changes in a timely manner.
• Collaborate to support training documentation updates for staff.
• Assist with continuous process improvement and troubleshooting projects.
• Ensure timely completion of documentation actions and current scheduling.

Skills

GMP knowledge

Technical writing

Documentation

CAPA

Change control

SOP creation

Training materials

Risk assessments

Education

Master's in Science/Engineering

Bachelor's in Science/Engineering + 2y experience

Associate's in Science/Engineering + 5y

High School Diploma + 8y

Job description

Merck & Co. seeks a documentation specialist to support manufacturing by drafting and revising GMP documents such as SOPs, protocols, and training materials. You will collaborate with cross-functional teams to ensure accurate, up-to-date records and assist in CAPA and deviation processes.

Ideal candidates hold a science/engineering degree with 2+ years in manufacturing, packaging, or quality within pharma/biotech. Onsite with occasional WFH after 6 months, standard hours 8-5.