What are the responsibilities and job description for the Quality Assurance Specialist III, Raw Materials position at Nitto Avecia?
About This Opportunity
As a Quality Assurance (QA) Specialist III, Raw Materials you will act as the lead QA representative for Raw Materials.
Key Responsibilities
As a Quality Assurance (QA) Specialist III, Raw Materials you will act as the lead QA representative for Raw Materials.
Key Responsibilities
- Oversees the QA raw material meetings to ensure releases on track.
- QA contact with Manufacturing, Supply Chain, Vendor Audit Team, and QC for all raw material issues, corrections, prioritizations, and requests.
- Reviews and releases raw material packets.
- Oversees training of new employees.
- Oversees raw material releases, tracking, prioritizing, requests, and reviews.
- Responsible for knowledge of SAP system for release/rejection of raw materials.
- Act as QA Lead for all raw material meetings including interaction with other departments such as QC, Milford Supply Chain, Cincinnati Supply Chain, etc.
- Responsible for ensuring MRBs for raw materials are initiated, labeled, and completed in a timely manner.
- Performs reevaluation release and part number transfers.
- Supports and reviews raw material CAPAs and/or Deviations for the QA Department.
- Responsible for raw material metrics.
- Supervises others as needed.
- Supports the Lead Raw Material Supervisor.
- Provide assistance during cGMP compliance inspections of the Milford facility. This includes the retrieving of quality documents/records/trend data and any other documentation requested during these inspections.
- Provide sound decision-making and guidance on all aspects of raw material release.
- Must be able to review AA reports, HVAC reports, and batch records on an as-needed bases.
- At least 4 years’ experience in a regulated/GMP industry, experience as QA in Pharmaceuticals or Biotechnology company required.
- Working knowledge and good understanding of 21 CFR 210, 21 CFR 211, and ICH Q7 regulations.
- Ability to work in a fast-paced environment consisting of internal and external team members with minimal oversight.
- Problem-solving skills with the ability to adapt to changing priorities and timelines.
- Ability to build positive working partnerships with other department teams.
- Experienced in the use of electronic systems such as eQMS.
- Requires the ability to gown into clean rooms and wear PP.E
