Senior Document Control Specialist

Actalent · Milford, MA, United States

Location
Milford
Job Type
Full-time
Posted
June 10, 2026

Job Description

Description

This role is responsible for maintaining quality documentation and managing document control systems at the site to ensure adherence to Current Good Manufacturing Practices (cGMP) and compliance with regulatory standards, including USFDA Title 21 CFR Parts 210 and 211, as well as Q7 Good Manufacturing Practice guidance for active pharmaceutical ingredients.

Skills

Document control, deviation management, batch record, gmp, change control, sop, Data entry, Quality assurance, Documentation management

Top Skills Details

Document control,deviation management,batch record,gmp,change control,sop

Additional Skills & Qualifications

Manages document control systems and processes to ensure their integrity and compliance with cGMP regulations. o Maintains master indices and tracking of standard operating procedures, deviations reports, change control reports, technical reports, protocols, batch record files, validation reports ...

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