AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.
AGC Biologics team is looking for a Supervisor, Document Control whose primary responsibility is coordinating Document Control personnel and activities related to the generation, approval, distribution and archiving of controlled documents at the Boulder and Longmont sites. Key contributions of the role will include writing, revising and maintaining Document Control procedures as well as participation in the development and deployment of Document Control tools and Document Management System. A successful candidate is able to work under minimal direction, has previous supervisory experience, and possesses the ability to work on very complex problems by analyzing procedures and data to create appropriate solutions.
- Provides direct supervision of Document Control team members.
- Promotes a team environment through training, mentoring, and motivating to achieve departmental daily requirements.
- Schedules and plans work assignments for department.
- Ensures the released documentation supporting Manufacturing, QC, Quality and other departments is current, accurate, and processed in a timely manner.
- Issues production batch records and labels for Manufacturing operations.
- Serves as primary point of contact for documentation and records.
- Provides support and guidance for the development and maintenance of site documentation, procedures, work instructions, and templates.
- Maintains the document storage room, and manages off-site archiving of documents.
- Creates and approves document change requests, manages document workflows, and releases documents to an effective state.
- Writes and maintains Document Control procedures.
- Develops and delivers training regarding Document Control processes and system changes.
- Supports internal and external audits and regulatory inspections.
- Performs routine and ad hoc Document Control metric reporting and analysis.
- Provides communication of the status of deliverables to customers, management, and stakeholders.
- Participates and/or leads continuous improvement initiatives.
- Engages in Corporate Quality initiatives and aligns best practices with other AGC sites.
KNOWLEDGE, SKILLS & ABILITIES:
- 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.
- BS degree in Chemistry, Biology, or other relevant discipline; work experience may substitute.
- Minimum of 5 years of QA or related experience.
- Previous management experience strongly desired.
- Previous Quality Systems Administration experience (e.g., TrackWise, or similar system).
- Experience interacting with FDA or other regulatory agencies strongly preferred.
- Equivalent education and experience may substitute for stated requirements
$71,400 - $89,300
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any
other characteristic protected by applicable laws, regulations and ordinances