Document Control Specialist

Job description

Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow. To support our growth plans, August is investing significant capital in a two-phase expansion project – including building a new state-of-the-art facility adjacent to our current facility. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August! The Document Control Specialist, Quality Assurance is responsible for supporting Quality Systems at August Bioservices. The Specialist works closely with cross-functional departments to ensure consistency of documentation practices across the company and is responsible for management and archival of all electronic and physical documents on-site at August Bioservices, and documents stored at an off-site third-party storage facility. ### Essential Duties & Responsibilities - Implement, coordinate, administer, and continuously improve the Document Control and Archiving Function of Quality Assurance, including the following: - Create and/or revise SOPs, batch records, and various GMP documents in support of site operations in eQMS. - Proofread, merge, and format documents as they progress through eQMS. - Reduce redundancy in procedures and GMP documents. - Initiate document reviews in eQMS. - Create, issue, and bind logbooks. - Participate and assist in 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. - Point of contact for documentation process improvement initiatives. - Serve as back-up for eQMS administrator, as needed. This may include assisting with on-boarding of new employees by creating users, assigning job codes requested by management, and creating new job codes as necessary for training. - Identify and resolve problems in collaboration with other departments. - Identify opportunities for improvement within scope of work. - Identify opportunities for improvement within scope of work. ### Qualifications - Bachelor of Science in a Life Sciences, Quality, or related field, or equivalent skills or experience. - 0 - 3 years of document management experience within a pharmaceutical FDA regulated environment. ### Knowledge, Skills, & Abilities - Strong organizational, multitasking, and problem-solving skills with great attention to detail. - Ability to manage competing priorities in a fast-paced environment. - Good communication skills, both written and verbal - Work well independently with minimal supervision - Self-motivated and adaptable, with a focus on continuous learning and development. - Good Documentation Practices - Good Manufacturing Practices ### Physical Requirements - Prolonged periods sitting at a desk and working on a computer. - Must be able to lift up to 15 pounds at times.