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Representative-QA MMQA

Representative-QA MMQA

Indiana StaffingIndianapolis, IN, US
2 days ago
Job type
  • Full-time
Job description

Position Brand Description

To provide support to the Indianapolis Device Assembly and Packaging (IDAP) materials management systems. The Materials Management representative provides Quality Oversight for the suppliers and materials utilized by the IDAP Site. This position supports all Materials Management activities relative to IDAP Products to ensure appropriate Quality Oversight.

Key Objectives / Deliverables

  • Coordinates the appropriate tasks to maintain the Approved Supplier List including additions, deletions and modifications to existing materials and suppliers.
  • Conduct material and supplier risk assessments and periodic reviews of supplier performance.
  • Coordinate and write Supplier, Service Provider, and Affiliate Quality Agreements, including networking with site resources to ensure compliance to associated requirements.
  • Provide input, guidance and recommendation for Supplier / Service Provider approval and certification activities.
  • Maintain complaint database (track supplier responses for warehouse, incoming and operations complaints).
  • Provide input and guidance to site activities (e.g. six sigma, new product / process development, change controls) as material quality SME.
  • Be able to perform materials SAP data steward functions, if necessary.
  • Review and Redline GMP documents, including specifications and procedures. Provide procedure ownership and subject matter expertise, as necessary.
  • Provide the voice of quality to the IDAP 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.
  • Lead, as required, local or global teams, committees or other groups to resolve quality issues and ensure site compliance to Lilly Standards and external regulations.
  • Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

Minimum Requirements

  • Bachelor's degree or equivalent experience in a science-related field.
  • Minimum 2 years of relevant experience in a regulated environment
  • Additional Preferences

  • Experience with Lilly deviation and change control processes.
  • Experience in material management, quality systems and cGMPs.
  • Proficiency with current computer systems and applications including Microsoft Office products, SAP, EDMS and TrackWise or similar systems.
  • Strong oral and written communication and interpersonal skills.
  • Ability to influence externally with suppliers and resources across sites.
  • Other Information

  • Overtime may be required.
  • May be required to respond to operational issues outside of core business hours and days.
  • Applicant may work in various areas within the IDAP Site. Some allergens are present in the IDAP Site.
  • Mobility requirements and exposure to allergens should be considered when applying for this position.
  • This position is located in Indianapolis, IN and regular in person attendance is required.
  • Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form.

    Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

    Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees.

    Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $169,400. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees.

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    Mmqa • Indianapolis, IN, US

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