Document Control Associate

Sebela Pharmaceuticals is a U.S. pharmaceutical company with a market-leading position in Gastroenterology and a focus on innovation in Women's Health. Our Vision is to build the leading Gastroenterology company in the U.S., with a complementary focus on innovation in Women's Health, premised on our expertise in pharmaceutical development and commercialization. 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.

We value dedication, energy, and enthusiasm, and we focus on innovation and results while striving to achieve our corporate mission and vision. Sebela Pharmaceuticals is committed to cultivating an inclusive environment where all employees are treated with respect. We accomplish this by fostering a culture of diversity, equity and inclusion, which is essential to innovation and continuous improvement. Sebela operates from three locations in Roswell, Georgia, Braintree and Holbrook, MA and headquarters in Dublin, Ireland.

Reporting to the Senior Manager of Documentation Control, 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.

PRINCIPAL DUTIES AND 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.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential function satisfactorily, be flexible in terms of work hours, and have strong knowledge and experience in Microsoft Office. The requirements listed below are representative of the knowledge, skills and/or abilities required.

• Experience in a cGMP-regulated pharmaceutical or biotech environment and familiarity with Good Documentation Practices and electronic document management systems preferred.
• High school diploma required. Associate or bachelor's degree preferred.
• 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.

Pay Range: $ per hour (this reflects our reasonable and good faith estimate of what will be paid at the time of posting). Competitive benefits package included.