Document Control Specialist — GMP & EDMS Expert

Cook Myosite Inc.; Pittsburgh (Allegheny County); On-site; USD 42,000 - 64,000; Full time

Job summary

Cook MyoSite Incorporated is seeking a full-time Document Control Assistant in Pittsburgh, PA to maintain the document management system and ensure quality and compliance for document control procedures in a cGMP environment.

The role focuses on supporting GMP manufacturing, controlling the EDMS and MasterControl software, and ensuring timely distribution and archival of controlled documents. Strong organizational and MS Office skills are essential.

Qualifications

• Bachelor's degree in life sciences, business, or related field, or related document control experience.
• Strong organizational skills and the ability to follow complex processes and systems.
• Proficiency in MS Office and effective written and verbal communication.
• Basic understanding of cGMP, 21 CFR Part 11, and related regulations.

Responsibilities

• Supports all activities related to Document Control in GMP Manufacturing.
• Maintains the document control and change management system.
• Serves as document control SME with knowledge of MasterControl and EDMS.
• Oversees daily operations of the Document Control process in MasterControl.
• Maintains files and controls access to original records and documents.
• Formats and proofreads quality system documents.
• Performs document control reviews on quality system records.
• Distributes latest revision documentation to users and removes obsolete docs.
• Supports management during regulatory agency and customer audits.

Skills

Organizational skills

Communication skills

MS Office proficiency

Team collaboration

Education

Bachelor's degree in life sciences, business, or related field

Tools

MasterControl

EDMS

Job description

Cook MyoSite Incorporated is seeking a full-time Document Control Assistant in Pittsburgh, PA to maintain the document management system and ensure quality and compliance for document control procedures in a cGMP environment.

The role focuses on supporting GMP manufacturing, controlling the EDMS and MasterControl software, and ensuring timely distribution and archival of controlled documents. Strong organizational and MS Office skills are essential.