- Perform quality technical support for commercial drug substance, drug product, finished goods
- Perform the role of lead Quality liaison for technical support with CMOs
- Provide technical investigation support in review of deviations and investigations to assess cGMP compliance of lots
- Lead off-site visits and teleconferences for discussion and review of supplier performance and cGMP compliance
- Provide person in plant assistance as necessary
- Review/Approve technical change controls as they relate to drug substance, drug product and finished goods
- Review/approve controlled cGMP documents including SOPs, Material Specifications, Investigation protocols/reports, Process Validation protocols/reports as applicable
- Identify and propose Quality process and system improvements. Lead improvement projects
- Serve as QA representative to cross functional project teams such as tech transfer, process validation, and process improvements
- Review and approve process, assay, and other validation protocols and reports as applicable
- Review and approve applicable sections of regulatory submissions
- Provide Global Quality Auditing SME support as necessary
- Provide support in the evaluation/implementation new technologies
- Support QA review and disposition of validation/commercial lots of drug substance, drug product, finished goods
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- BA/BS (or Master's) in any Life Science discipline preferred, and/or 10+ years experience
- Understands and applies good working knowledge of quality and GMP principles.
- Ability to handle multiple tasks concurrently and in a timely fashion.
- Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.
- Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers and management.
- Must display eagerness to learn and continuously improve.
- Positive work attitude that supports teamwork and continuous improvement.
- Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
- Must be experienced in Microsoft Office applications, especially Word, Excel and PowerPoint.
- OSD, Parenteral and/or Biologic manufacturing knowledge is preferred.
- Wrist and hand motion (e.g. typing, writing)
- Must be able to work in controlled or clean room environments requiring special gowning
- Willingness to travel to various meetings or client sites, including overnight trips
- Requires approximately 25% travel
Empowering Our People to Shine.
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