GMP Document Control Specialist (eQMS)

August Bioservices, LLC; Nashville (TN); On-site; USD 55,000 - 85,000; Full time

Job summary

August Bioservices, LLC in Nashville, TN seeks a Document Control Specialist within Quality Assurance to ensure documentation consistency and regulatory compliance across the site. The role focuses on controlling electronic and physical records, SOPs, and GMP documents.

You will manage eQMS workflows, support audits, and drive process improvements while collaborating with cross-functional teams to maintain data integrity and training records.

Qualifications

• Bachelor of Science in Life Sciences, Quality, or related field.
• 0-3 years of document management experience within a pharmaceutical FDA-regulated environment.
• Experience with GMP documentation practices is preferred.

Responsibilities

• Implement, coordinate, administer, and continuously improve the Document Control and Archiving Function of Quality Assurance.
• Create, revise SOPs, batch records, and GMP documents in eQMS to support site operations.
• Proofread, merge, and format documents as they progress through eQMS.
• Support site audits and inspections as needed.
• Provide support to cross-functional teams routing documents through MasterControl and ensure consistency of documentation practices across the site/company.

Skills

Organizational skills

Multitasking

Problem solving

Attention to detail

Communication skills

Independence

Continuous learning

Documentation practices

Good manufacturing practices

Education

Bachelor of Science in Life Sciences, Quality, or related field

Tools

MasterControl

eQMS

Job description

August Bioservices, LLC in Nashville, TN seeks a Document Control Specialist within Quality Assurance to ensure documentation consistency and regulatory compliance across the site. The role focuses on controlling electronic and physical records, SOPs, and GMP documents.

You will manage eQMS workflows, support audits, and drive process improvements while collaborating with cross-functional teams to maintain data integrity and training records.