Document Control Specialist Job Nashville area,Tennessee USA,Quality Assurance

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.

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
Create, issue, and bind logbooks
Participate and assist in site audits and inspections, as needed
Provide support to cross-functional teams routing documents through Master Control 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

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 Master Control and ensure consistency of documentation practices across the site/company
Point of contact for documentation process improvement initiatives
Serve as back-up for…