Life Sciences

LKC MMQA Rep

Contract

Medasource

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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%) 

 

LKC MMQA Rep Pleasant Prairie, Wisconsin

For over 16 years, Medasource has established and maintained relationships that are designed to meet your IT staffing needs. Whether it’s contract, contract-to-hire, or permanent placement work, we customise our search based upon your company’s unique initiatives, culture and technologies. With our national team of recruiters placed at 21 major hubs around the nation Medasource finds the people best-suited for your business. When you work with us, we work with you. That’s the Medasource promise.

Medasource is an equal opportunity employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

Benefits & Perks:

Medasource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.

Pay Disclaimer:

The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.

JO-2408-149040

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