Quality Assurance Specialist III, Raw Materials

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: 

• 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.

Required Skills/Abilities:

• 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