Quality Control Representative

  • Indianapolis, IN
  • Posted 20 hours ago | Updated 12 hours ago

Overview

On Site
$$ 34.87 / hr
Contract - W2
Contract - To 2027-02-28

Skills

Quality Control Representative

Job Details

Job Description:
Responsibilities:
  • The Global Supplier Quality Candidateagement (GSQM) contractor is responsible for executing the Global Supplier Quality Candidateagement (GSQM) Program in support of the new site expansions.
  • The position ensures that Supply Chain & Affiliates organization provides central execution support in onboarding suppliers, materials, and GMP service providers in a timely manner to support project timelines with new site expansions.
  • The contractor is responsible to partner, consult and interface with business partners to implement across networks and functions to meet business needs.
  • The GSQM process focus is to provide a globally holistic process in which GMP supplier and GMP service provider's Supplier Quality Candidateagement activities are globally consistent, available, and executed by a central function to maintain patient safety, product quality, and technical elements at the highest standard and compliance.
Key Objectives/Deliverables:
  • The following activities will be performed according to established procedures, guidelines, forms, and tools. These responsibilities are not intended to be all-inclusive nor are they all to be performed by one person:
  • Execute the 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 the site expansions on behalf of the sites. CollaboXX with SAP Business QA as needed.
  • CollaboXX and communicate with manufacturing/affiliate sites across the networks (API / Candidateufacturing / 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 Candidateagement (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 Candidateufacturing Plants (MPs) materials.
  • Partner with Global TS/MS to develop and execute the material risk control stXXgy (material risk, product acceptance risk, specification controls).
  • Provide input and support for supplier related change controls.
  • This implies establishment and maintenance of a comprehensive knowledge of all applicable regulations, technical knowledge, and training to meet these responsibilities.
Personal Development:
  • Be continually aware of current industry trends and regulatory agency interpretation of GMP/cGMP and other relevant requirements, in particular, those related to the Supplier Candidateagement Programs.
  • Maintain good interpersonal and communication skills with business areas with emphasis on verbal and technical writing skills.
  • Complete required training and qualifications for the roles identified in the Learning Plan (LP).
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 Candidateagement.
  • 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:
  • Five (5) years of minimum experience at manufacturing site within QA organization.
  • Good knowledge of quality management; Supplier Quality Candidateagement; ISO and GMPs.
  • PowerApps, PowerBI, Tableau experience.
  • Knowledge of GQS, CQP, LQP.
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