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Supplier Quality Specialist
Posted on Nov. 20, 2024
- Indianapolis, United States of America
- 33.0 - 40.0 USD (hourly)
- Full Time
Job Responsibilities:
- Maintain and update the certified supplier list.
- Ensure supplier assessments are current and reflect quality risks.
- Ensure compliance with US and international regulatory requirements (e.g., FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP).
- Act as the site auditor for suppliers, ensuring adherence to the supplier audit schedule.
- Lead the supplier change control (notification) process.
- Initiate and manage SCAR deviations related to supplier defects.
- Provide support during FDA or other regulatory agency on-site audits.
- Serve as the site’s Subject Matter Expert (SME) for MSD.
Qualifications:
- Bachelor’s degree in Biology, Chemistry, or a related field required.
- Minimum of 3 years of relevant experience in supplier quality or a similar role.
- Experience with investigating deviations and out-of-specification issues is preferred.
- Proficiency in Microsoft Office Suite and strong computer skills, including data entry and personal computer use.
- Strong knowledge of cGMP guidelines and their application in a pharmaceutical manufacturing setting.
Job Type: Full-time
Pay: $33.00 - $40.00 per hour
Expected hours: 40 per week
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
Work Location: In person
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