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Quality Specialist (Supplier)
Raleigh, NC, US
Scientific
Bachelors Degree
Full Time, Direct Hire
$125,000/year
Experienced (Non-Manager)
On-site
Biotechnology/Pharmaceuticals
First Shift (Day)
Raleigh, NC, US
$125,000/year
Experienced (Non-Manager)
Full Time, Direct Hire
Biotechnology/Pharmaceuticals
On-site
Scientific
Bachelors Degree
First Shift (Day)
Job details
Kelly Science is seeking a Quality Specialist (Supplier) to join a growing team located in Raleigh, NC.
Salary: $125,000/year
Shift: Monday-Friday 1st Shift (Fully on-site)
Employment Type: Full Time; Direct Hire
Summary:
The Supplier Quality Specialist ensures GMP compliance of all materials by partnering with cross-functional teams and overseeing supplier quality for the Raleigh facility.
Job Responsibilities:
- Oversee suppliers supporting GMP manufacturing, including qualification, audits, and risk management.
- Maintain relationships with critical and sole-source suppliers, manage quality agreements, and assess the impact of supplier changes.
- Ensure supplier deviations, quality events, and CAPAs are logged, investigated, and resolved per procedures.
- Support risk assessments for suppliers and materials, including data integrity and supply continuity.
- Lead routine supplier meetings and manage Supplier Corrective Action Reports (SCARs).
- Assist with audits/inspections, create/revise SOPs, and support investigations and internal audits as needed.
- Perform other duties as assigned by management.
Qualifications:
- Bachelor’s degree in a scientific related field preferred
- 5-8 years of quality assurance experience in a GMP-regulated environment
- Strong experience in authoring, reviewing, and maintaining controlled GMP documentation
- Advanced expertise in document lifecycle management, change control, deviation support, and CAPA documentation strongly preferred
- Ability to independently audit new and approved suppliers strongly preferred.
- Demonstrated cross?functional collaboration skills with Supply Chain, Manufacturing, and Regulatory teams
Interested? Please apply today for immediate consideration!
10298400
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