Supplier Quality Specialist

d04444ef-3464-49c4-81aa-2d3eeb7dfc39•Durham, NC

3d•Onsite

About The Position

The Supplier Quality Specialist is responsible for supporting the Supplier Quality function through execution of raw material inspection, review, and release activities to ensure timely availability of materials for GMP manufacturing operations. This role performs routine supplier quality activities, supports incoming material disposition, coordinates third-party testing activities, maintains associated quality records, and assists with supplier quality investigations under the guidance of Supplier Quality leadership. This position contributes to maintaining compliance with applicable GMP requirements while supporting continuity of material supply for manufacturing operations.

Requirements

High School or GED required, Bachelor’s Degree, preferred
2-4 years of experience in Quality within the biotechnology, pharmaceutical, or medical device field, required
Minimum 2 years of experience in Raw Material programs, required
Strong understanding of regulations and compendial guidance for Raw Material program applications, including USP, EudraLex, PDA technical reports, FDA Guidance for Industry
Working knowledge of cGMP regulations and quality system requirements.
Understanding of raw material release processes and controlled documentation practices.
Ability to review quality records for accuracy, completeness, and compliance.
Familiarity with supplier documentation including Certificates of Analysis, specifications, and testing requirements.
Ability to coordinate activities with Manufacturing, Warehouse, QC, Supply Chain, and external testing laboratories.
Strong attention to detail and data review skills.
Basic knowledge of deviations, CAPAs, change controls, and quality investigations.
Effective verbal and written communication skills.
Ability to prioritize multiple activities and meet established timelines.
Proficiency with Microsoft Office applications and electronic quality systems.

Nice To Haves

Prior experience supporting regulatory inspections a plus

Responsibilities

Perform raw material and component release activities in accordance with approved procedures and specifications.
Review incoming material documentation, including Certificates of Analysis (CoA), Certificates of Conformance (CoC), shipping records, and receipt documentation.
Coordinate submission of samples to qualified third-party testing laboratories and track testing status to support material release timelines.
Review third-party laboratory test reports against approved specifications and escalate discrepancies, atypical results, or quality concerns.
Execute incoming inspection activities for raw materials and components as required.
Maintain raw material release records, inspection documentation, and associated quality system documentation.
Assist with supplier investigations, nonconformances, deviations, complaints, and supplier corrective actions (SCARs).
Support supplier qualification and monitoring activities through collection and maintenance of supplier quality documentation.
Generate and maintain raw material release metrics and reporting tools.
Participate in continuous improvement initiatives related to material release processes and supplier quality programs.
Support internal audits, supplier audits, and regulatory inspections by providing documentation and subject matter support, as assigned.
Assist in the review and revision of SOPs, forms, specifications, and work instructions associated with raw material programs.
Support inventory disposition decisions through accurate and timely execution of release activities.
Perform other Quality Assurance responsibilities as assigned.