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Quality Specialist
Quality SpecialistJoulé • Indianapolis, IN, US
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Quality Specialist

Quality Specialist

Joulé • Indianapolis, IN, US
3 days ago
Job type
  • Permanent
  • Temporary
Job description

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Job Title

Quality Specialist

Location

Indianapolis, IN

Work Schedule : Mon - Fri, 8am - 5pm

Pay Range

$30 - $34.85 / hr

Type : 18-month contract, Potential for extension or conversion to permanent

Overview

Leading pharmaceutical company looking for an experienced Quality Control Representative. Ideal candidates should have at least5 years of experience at a manufacturing site within QA organization. Required skills includeexperience in change management and MS office Suite (Teams, OneNote, OneDrive, SharePoint, PowerPoint and Excel).

Requirements

Education :

  • Associate's degree or other advanced education or training

Experience :

Excellent knowledge in manufacturing operations, quality, and supplier quality management is preferred.

  • Experienced in SAP, TrackWise, and Veeva QualityDocs is preferred.
  • Experienced in Change Management.
  • High ability in execution of MS Office basic suite (Teams, OneNote, OneDrive, Sharepoint, PowerPoint, Excel).
  • Demonstrated ability to communicate and deliver constructive feedback to customers, including excellent interpersonal and oral presentation skills…. as well as strong written communication skills.
  • Creativity in strategy development and problem solving.
  • Ability to work independently and as part of a team with minimal supervision.
  • Ability to communicate, convince, train.
  • Additional Skills / Preferences includes :

    Five (5) years of minimum experience at manufacturing site within QA organization

  • Good knowledge of quality management; Supplier Quality Management; ISO and GMPs
  • PowerApps, PowerBI, Tableau experience
  • Knowledge of GQS, CQP, LQP
  • Responsibilities

    Execute supplier quality management process in compliance with Global Quality Standards (GQS305, GQS301 & GQS307) in addition to others, as applicable

  • Assist procurement, supply chain, GQAAC, MMQA, TS / MS, and manufacturing functions in identifying and managing material suppliers and GMP Service Providers.
  • Execute SAP and TW138 activities in the approved supplier list (ASL) process of suppliers and / or GMP service providers for Lilly site expansions on behalf of the sites. Collaborate with SAP Business QA as needed.
  • Collaborate and communicate with manufacturing / affiliate sites across the networks (API / Manufacturing / Packaging / DPEM / APIEM / Devices) to ensure process execution is robust and effective and barriers are escalated.
  • Develop and communicate processes to manage the Global Supplier Quality Management (GSQM) process and related initiatives.
  • Provide support to ensure maintenance of the supplier quality management data, including approved supplier and GMP service provider list, in the appropriate systems, e.g., SAP, VeevaVault (QDocs), TrackWise.
  • Support execution of Certification Package Review Board and global certification packages for global SAP Manufacturing Plants (MPs) materials.
  • Partner with Global TS / MS to develop and execute the material risk control strategy (material risk, product acceptance risk, specification controls).
  • Provide input and support for supplier related change controls.
  • Benefits

    System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

    Ref : #558-Scientific

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