Description
Will assist staff in managing the performance, quality systems and compliance aspects related to material suppliers of excipients, materials and components to ensure consistency and compliance with regulatory expectations and company standards.Responsibilities:
- Perform a range of duties within the QA group, associated with oversight and support of supplier program
- Responsible for regular communication of quality status and escalation of supplier related quality issues, maintaining a close working relationship with inventory Management and QA supplier management staff.
- Monitor and report supplier quality system performance and risk rating Supplier Program Specific Activities
- 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
- Provide updated supplier information.
- Support Change Management activities of suppliers as requested
- Update supplier implementation tracking spreadsheets
- Support compilation of data to complete supplier reassessments
- Research existing supplier audit reports and audit notices
- Complete supplier qualification summary reports (as applicable)
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 and GDMS is desirable.
- Must be organized and attentive to detail with good communication skills, good quality mindset and good computer skills
- Word, Excel
- Experience in supplier management and supplier risk assessment desirable
- Experience in a Good Manufacturing Practices (GMP) environment preferred
- Calm personality; takes direction easily; focused and not easily distracted