Document Control Specialist I - Senior

About AGC Biologics 
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.   

JOB SUMMARY

This position includes maintenance of the Quality System associated with Document Control.  Specifically the role will maintain Document Control procedures as well as participation in the development and deployment of Document Control tools and Document Management System. The role will include activities related to the issuance, filing, reconciliation and archival of controlled documents.  This position requires a background in QA, technical writing skills and inter-departmental collaboration. 

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Author and maintain Document Control procedures and templates.
• Provide support for the development and maintenance of site documentation, procedures, work instructions, and templates.
• Participate in the development and roll-out of document control tools.
• Issue production batch records and labels for manufacturing operations.
• Issue logbooks, protocols, reports and other controlled documents for various departments.
• Follow policies, SOPs and work instructions to support the document approval process.
• Develop and deliver training regarding document control processes and system changes.
• Execute the process for filing, reconciliation and archival of controlled documents.
• Support internal and external audits and regulatory inspections as required.
• Perform routine and ad hoc document control metric reporting and analysis.
• Monitor documentation system function; investigate and coordinate with IT on issues.
• Communicate the status of deliverables to customers, management, and stakeholders.
• Work on complex documentation problems, analyzes procedures and data to create appropriate solutions.
• Support Change Control related to Document Control processes, when required.
• This position is a delegate for other Document Control Specialists and, depending on level, this position may be a delegate of the Document Control Supervisor.

KNOWLEDGE, SKILLS, AND ABILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• Strong understanding of cGMPs and quality systems.
• Excellent problem solving skills.
• Excellent project management skills.
• Excellent technical writing skills and verbal presentation skills.
• Excellent organizations skills and attention to detail.
• Strong computer skills with MS Office (e.g., Word, Adobe, Visio and Excel).
• Innovative, proactive, and resourceful; committed to quality and continuous improvement. 
• Ability to exercise judgment within defined practices and policies in performing Document Control functions with input from Supervisor.
• Ability to work independently on routine work tasks, and under only general instructions on new assignments.
• Ability to interact constructively and efficiently with co-workers within and across departments.

EDUCATION and/or EXPERIENCE 

• BS/BA in science-related field desired; combination of education and related work experience may be considered.
• Previous experience in QA or related document control experience, as required below:
• Specialist I – 0 – 2+ years
• Specialist II – Minimum 2 years
• Specialist III – Minimum 5 years
• Specialist Senior – Minimum 8 years
• Experience with relevant software and databases required (e.g. MasterControl Document Management System, TrackWise, or similar system)
• Experience interacting with FDA or other regulatory agencies strongly prefer