Doc Control Specialist

Job Title: Documentation Control Specialist

Location: Princeton, NJ (Onsite)

Type: Contract – 4 Months | Full-Time

Compensation: Competitive, commensurate with experience

Company Overview

Our client is an emerging Contract Development and Manufacturing Organization (CDMO) with a strong operational footprint in India and a growing presence in the United States. They provide high-quality biologics manufacturing services to global pharmaceutical clients.

Position Overview

The Documentation Control Specialist will manage and maintain documentation in support of the Quality Management System (QMS), ensuring compliance with GMP and FDA standards. This role covers production and QC record control, archive management, and audit readiness. The ideal candidate brings strong regulatory documentation knowledge and electronic document system experience in a fast-paced, growth-oriented environment.

Key Responsibilities

• Manage daily operations of the document control function.

• Issue, track, and archive production and QC working records.

• Perform True Copy scanning and maintain associated documentation.

• Write and implement procedures for document archiving and compliance.

• Oversee the document lifecycle: version control, distribution, retention, and destruction.

• Maintain control of manual GMP processes, including logbooks.

• Support continuous improvement of the Document Management System (DMS).

• Review and verify procedures in MasterControl for accuracy and compliance.

• Collaborate with cross-functional teams to ensure documents reflect current practices.

• Provide audit support for internal and external inspections.

• Perform additional quality-related tasks as assigned.

Qualifications

Education

• Bachelor’s degree in a Life Science discipline, or equivalent.

• Note: 4+ years of relevant industry experience may substitute for a degree.

Experience

• Minimum 2 years of GMP document control experience within pharmaceutical or biopharma.

• Experience with electronic document systems (QDMS, EDMS, LMS, E-Doc, etc.).

• Strong understanding of FDA and GMP documentation procedures.

• Skilled in Microsoft Office (Word, Excel, PowerPoint) and Adobe Acrobat.

• Proven success in fast-paced, high-growth environments.

Soft Skills

• Excellent written, verbal, and interpersonal communication skills.

• Ability to work effectively across multicultural teams and management levels.

• Strong regulatory knowledge and ability to articulate requirements clearly.

• Comfortable working in an open office environment.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, veteran status, or other protected status.