Document Control Associate

Sebela Pharmaceuticals • Holbrook, MA

5d • Onsite

About The Position

Sebela Pharmaceuticals is a U.S. pharmaceutical company with a market-leading position in Gastroenterology and a focus on innovation in Women’s Health. Braintree Laboratories, Inc., a part of Sebela Pharmaceuticals, has its contract development and manufacturing organization (CDMO) in Holbrook, MA, offering pharmaceutical-development and in-house manufacturing services for specialty gastroenterology products. This role will support document and records management activities in compliance with cGMP, GDP, and company procedures, including document distribution, maintenance, retrieval, archival, and audit readiness.

Requirements

• Strong knowledge and experience in Microsoft Office.
• High school diploma required.
• Excellent written and verbal communication skills.
• Exceptional organization and document management skills.
• Ability to multi-task.
• Proficiency in Microsoft Office including Microsoft Word and Excel required.

Nice To Haves

• Experience in a cGMP-regulated pharmaceutical or biotech environment.
• Familiarity with Good Documentation Practices and electronic document management systems preferred.
• Associate or bachelor’s degree preferred.

Responsibilities

• Maintain the QA Document Control Records room and associated archive locations as per applicable SOPs.
• Provide support to internal and external audits by retrieving records promptly, reconciling files, and maintaining audit-ready documentation.
• Collaborate with Quality Assurance, Manufacturing, Quality Control, Validation, and other functional groups to support documentation requests and compliance needs.
• Scan and maintain electronic records in associated Document Control network folders.
• Manage the issuance, distribution and filing of completed logbooks and Laboratory Notebooks.
• Distribute and update SOP binders in all satellite locations.
• Issue working Batch Records.
• Assist in drafting, formatting, revising, and maintaining document control procedures and related controlled documents as required.

Benefits

• Competitive benefits package included.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED