GMP Technical Writer for Manufacturing & QA Documentation

Aditi Consulting; New Albany (OH); On-site; USD 45,000 - 48,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Health savings accounts

Paid time off

Bereavement leave

401(k) with employer match

Life and disability insurance

Commuter benefits

Dependent care FSA

Discretionary bonus

Job summary

Aditi Consulting is seeking a GMP-literate professional to support the manufacturing team by drafting and revising SOPs, protocols, and training materials in a regulated environment. You will develop and update technical content, maintain quality system records, and collaborate across departments to ensure documentation accuracy.

The role requires experience with deviations, CAPA, change controls, and strong written and oral communication.

Qualifications

• Master's or higher in science/engineering with manufacturing/QA exposure in pharma/biotech.
• Experience with GMP pharma environment and technical writing.
• Ability to translate technical info for operators.

Responsibilities

• Draft and revise SOPs, protocols, technical reports, and training material in GMP environment.
• Develop, review, and update manufacturing documentation and risk assessments.
• Provide technical and clerical support for documentation preparation and data tracking.
• Liaise with cross-functional teams on documentation changes.
• Support training documentation for manufacturing staff and change controls.
• Contribute to continuous improvement and troubleshooting projects.
• Ensure timeliness and accuracy of documentation actions.

Skills

GMP background

Deviation/investigation ownership

Excellent written and oral comms

Change control experience

Education

Master's Degree in Science/Engineering

Bachelor's Degree with 2 years pharma/biotech quality experience

Associate’s Degree with 5 years pharma/biotech experience

Tools

Veeva

Job description

Aditi Consulting is seeking a GMP-literate professional to support the manufacturing team by drafting and revising SOPs, protocols, and training materials in a regulated environment. You will develop and update technical content, maintain quality system records, and collaborate across departments to ensure documentation accuracy.

The role requires experience with deviations, CAPA, change controls, and strong written and oral communication.