Documentation Specialist

Contractor Role Description: Supplier Management

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.

Responsibilities

Key responsibilities are expected to encompass the following

• 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

Specific Activities May Include

• 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.
• 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, PDOCS 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

Thanks

Regards

Ricky