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. 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.
Manufacturing Document Control Specialist III
Responsible for activities related to guidance, identification, collection, distribution, review, and filing of controlled documentation (Batch/Production Records, Logbooks, Forms, etc.) within Manufacturing.
- Ensure that manufacturing documentation supporting operations is current, accurate, and processed in a timely manner.
- Provide guidance to Manufacturing personnel as it relates to GMP/in plant GMP documentation.
- Perform routine and ad hoc document control metric reporting and analysis.
- Identify continuous improvement opportunities.
- Participate in Kaizen, SQDCM, GEMBA, and problem solving meetings.
- Oversee issuance and storage of controlled documents.
- Manage, organize, and maintain the Manufacturing Document Review Room for storage of controlled documentation.
- Provide copies of controlled documents to AGC staff on an as needed basis.
- Provide timely and accurate, right the first time GMP document review.
- Support internal and external audits and regulatory inspections.
- Review and identify documentation discrepancies.
- Collaborate with internal resources to efficiently and effectively resolve documentation related issues.
- Initiate and/or assist with quality records in Quality Management System (QMS) as needed.
- Scan and enter documentation into Quality Management Systems as directed.
- Assist and comply with Quality Assurance documentation functions.
- Adhere to internal/external guidelines, specifications, and regulatory requirements while reviewing documentation.
- Comply with company policies and procedures.
KNOWLEDGE, SKILLS & ABILITIES:
- Demonstrate understanding of cGMP, GDP, and QMS
- Ability to learn and understand technical aspects within documentation
- Ability to maintain positive cross-functional and collaborative relationships.
- Ability to maintain a positive attitude and ability to perform under pressure
- Ability to exercise judgment within defined practices and policies in performing document control functions with input from supervisor.
- Must be highly organized
- Must be a team player
- Demonstrated ability to problem solve
- Strong communication skills, including both verbal and written
- BS in scientific discipline; with a minimum of 5-7 years’ relevant experience
- Experience with electronic Quality Management System (e.g. MasterControl, TrackWise, etc.) preferred
- Experience with asset management software (Blue Mountain, Maximo, etc.) preferred
- Equivalent education and experience may substitute for stated requirements
Experience interacting with FDA or other regulatory agencies preferred
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.