Address
Form of workThe Supplier Coordinator is primarily responsible for coordinating supplier approval tasks and for maintaining the Approved Supplier List. The Supplier Coordinator will also be responsible for coordinating documentation with suppliers when quality issues are identified and when notified of changes. Additionally, the Supplier Coordinator will work closely with Supply Chain to facilitate supplier approval activities.
Responsibilities:
Execute supplier qualification activities for existing and new suppliers per applicable procedures
Drive on-time completion of re-certification activities for existing suppliers
Review and evaluate self-assessment documentation against regulations, current standards and guidelines to ensure compliance.
Revise self-assessment templates as necessary
Draft and maintain Supplier History Evaluation documents for each supplier
Maintain supplier infocards in MasterControl
Participate in supplier audits including on-site inspections, when required
Maintain a history of audits performed and schedule repeat audits as required
Coordinate supplier quality alert activities and the corresponding documentation
Coordinate supplier change notification documentation
Assist with the coordination of regulatory and customer audits
Bachelor’s degree preferred. (Science or Technology related)
3 to 5 years experience with a quality assurance background preferred
Thorough knowledge of cGMP/ 21CFR with related experience in regulatory and compliance
Experience with FDA regulations
Strong critical thinking skills
Good technical writing skills
Auditor certification is a plus
