Description
Summary:- This Quality position is considered a global role reporting into the supplier management team within PharmSci QA who is responsible for supporting the Pharmaceutical Sciences R&D organization.
- The colleague will assist staff in managing supply chain security and performance of external parties who provide materials for GMP manufacturing.
- Perform a range of duties within the Pharm Sci QA group, associated with oversight and support of the supplier program (and may also support the external vendor inventory management function)
- Support efforts to introduce enhancements to the supplier program
- Responsible for regular communication of quality status and escalation of supplier related quality issues, maintaining a close working relationship with Inventory Management, PharmSci QA and other sites across the network.
- Review supplier documentation to support the creation of material supply channels and ensure supply chain security
- Interface with Inventory Management Personnel to obtain supply chain documentation
- Collect data to support completion of risk-based supplier assessments
- Interface with MSQA group to provide updated supplier information
- Update supplier tracking spreadsheets
- Research existing supplier audit reports and audit notices
- Execute QA review and release of routine and high priority transfer/shipment requests and packaging and ancillary components,
- Execute extension of expiry dating,
- Point of Contact for assessment of shipment damage
- Responsibilities may include occasional special project work and other duties as assigned by the department lead or site leadership.
Qualifications:
- Minimum BS Degree or equivalent in a scientific discipline. Knowledge of cGMP, including regulations related to supplier management programs is desirable
- Prior quality assurance experience supporting supplier management is desirable.
- Experience using SMS, M3, QTS, and GDMS is desirable.
- Solid understanding of cGMPs as they relate to assigned tasks
- Professional demeanor exhibited through the proficient use of email and phone etiquette
- Ability to shift priorities and tasks throughout the workday to meet business requirements
- Supplier Management, Supplier Quality, Ability to Follow-up, Ability to meet deadlines, Ability to Work Independently, Advanced Communication Skills, Detail oriented, Oral and Written Communication Skills, Project Management