Quality Assurance Representative

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%)
25 days ago