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Hybrid Document Control Specialist bei August Bioservices

August Bioservices · Nashville, Vereinigte Staaten Von Amerika · Hybrid

Microsoft Excel

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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.


    • At August Bioservices, Our Credo is our culture. Everything we do, we do with great care. We believe in the promise of discovery and the power of science to transform lives. We assert that excellence is not a static destination, but a standard, and an every-day measuring stick of our advancement. We aspire to unlock the potential in every person, every process and every molecule – from start to finish. We are committed to doing the right thing the first time and every time, meeting or exceeding all regulatory requirements. We strive to be exceptional, preferred and indispensable partners for our customers; responsible and engaged citizens within our communities; and active, mindful stewards of our environment.
     
    We are August Bioservices. We are pointing the way forward. If this sounds like your kind of working environment, we want you on our team!

    August Bioservices  is an equal opportunity employer and values diversity. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.
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