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Quality Assurance Representative

2 months ago

Pleasant Prairie, United States Medasource Full time

Title: Materials Management Quality Assurance Representative

Client: Large Pharmaceutical Manufacturing Client

Location: Pleasant Prairie, WI

Contract Duration: 12-24 months w/ extensions

Benefits: Health, Dental Vision

Shift: 1st


Key Objectives/Deliverables

• Establish and maintain site the supplier quality management program in partnership with other Client manufacturing sites and global.

• Conduct material and supplier risk assessments and classifications for materials and supply chain participants where required.

• Formally approve or reject material or supply chain participant as appropriate based on assessment/classification result.

• Conduct periodic reviews of supplier performance, formally approve or reject material or supply chain participant as appropriate based on result of periodic review.

• Conduct or ensure that initial and ongoing supplier quality management activities take place as needed, these include but are not necessarily limited to:

• Initiation and review of supplier questionnaires

• Quality audits take place in accordance with Global requirements

• Initiation, review and updating of Quality Agreements

• Coordinate the appropriate tasks to maintain the Approved Supplier List including additions, deletions and modifications to existing materials and suppliers.

• Supplier Quality Management related activities and transactions within SAP and Trackwise

• Provide input, guidance and recommendation for Supplier / Service Provider approval and certification activities.

• Responsible for materials and supplier complaint handling

• Maintain complaint database (track supplier responses for warehouse, incoming and operations complaints).

• Provide the voice of quality to the Parenteral Supplier Committee, providing input and support as needed in order to ensure compliance.

• Support regulatory inspection activities as needed by providing documentation and SME support.

• Track and report materials management metrics to Supplier Relationship Meetings, supplier committees, and Materials Management Governance Committee.

• Work with global resources, as necessary, to achieve compliance with requirements.


Minimum Requirements:


• Bachelors’ Degree or equivalent experience in a science - related field

• 2+ years demonstrated relevant experience in a GMP facility

• Proficiency with current computer systems and applications including Microsoft Office products, LMS, EDMS and TrackWise, MasterControl or similar systems

• Strong oral and written communication and interpersonal skills

• Ability to influence externally with suppliers and resources across sites

• Demonstrated technical writing skills.

• Experience in material management, quality systems and cGMPs

Other Information:


• Overtime may be required.

• May be required to respond to operational issues outside of core business hours and days.

• Position may require travel (10%)