cGMP Documentation Specialist | Change Control

Collabera; Worcester (MA); On-site; USD 50,000 - 70,000; Full time

Benefits offered by this job

Paid vacations

Medical, Dental and Vision insurance

401(k) retirement savings plan

Life Insurance

Disability Insurance

Job summary

A leading IT services company is seeking a Documentation Control Specialist responsible for maintaining an accurate documentation change control system. The candidate will assign Change Request numbers, prepare manufacturing records, and maintain controlled documentation. Ideal candidates should have 3-5 years of experience, strong organizational skills, and attention to detail. This position is initially for 12 months with potential for extension based on performance.

Qualifications

• 3-5 years of experience in documentation or administrative roles.
• Ability to maintain organized filing systems.
• Proficient in document preparation and editing.

Responsibilities

• Maintain an accurate, cGMP compliant documentation change control system.
• Assign Change Request numbers for document or data changes.
• Prepare manufacturing records for issuance to production.
• Maintain tracking and distribution of controlled documentation.
• Route documents for approval and assist in audits as needed.

Skills

Organizational skills

Attention to detail

Office experience

Education

Bachelor's degree or equivalent

Job description

A leading IT services company is seeking a Documentation Control Specialist responsible for maintaining an accurate documentation change control system. The candidate will assign Change Request numbers, prepare manufacturing records, and maintain controlled documentation. Ideal candidates should have 3-5 years of experience, strong organizational skills, and attention to detail. This position is initially for 12 months with potential for extension based on performance.