Quality Documentation Manager
POSITION OBJECTIVE: Manage manufacturing facility’s Quality Management Systems, including Document Management, Training and CAPA Programs.
This position is based on site in our Dunkirk, New York facility. Remote work is not an option for this role.
Essential Job Functions/Responsibilities
- Administer site document management program, including: review, approval and archival of relevant site quality system documents (SOP’s, Batch Records, Specifications, Validation Documents, Testing Worksheets, etc.).
- Administer the site training program, including new hire orientation, job based training curriculums and internal/external event based trainings.
- Administer MasterControl eQMS for site including, Documents, Training and Quality Events Modules.
- Support management review process, including metrics development and implementation.
- Build and maintain a collaborative working relationship within own and other business units.
- Provide support for activities associated with the development of new products, processes, systems, and facilities and support existing products, processes, systems, and facilities.
- · Lead document management and training teams to efficiently accomplish site and organizational goals.
- Help support the Vendor Qualification program.
- Maintain site audit readiness and assist in hosting of customer and regulatory audits.
- Support the achievement of the Lean Manufacturing goals by performing responsibilities in an effective and timely manner.
- Identify areas for improvement to achieve effectiveness by leading and participating improvement projects.
- Performs specification and batch record review to support product release.
- Supports product holds, recalls, and fields alert as necessary.
- Other responsibilities as may be assigned.
Required Education & Qualifications
- A minimum of a Bachelor’s degree in an applicable life-sciences, engineering, or public health field.
- A minimum of 5 years of regulatory experience, preferable commercial pharmaceutical manufacturing activities with at least 2 years of team leadership experience.
- Experience with Electronic Quality Management Systems strongly preferred.
- Ability to effectively communicate to multi levels in the organization including management specifically on the risks and benefits of decisions impacting site compliance.
- Experience with internal auditing, CAPA management, metric development and maintenance, continuous improvement methodologies, root cause analysis
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.