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Quality Control / Quality Assurance Specialist

Alpha Consulting

This is a Full-time position in Phoenix, AZ posted July 12, 2021.


Project Description:
The Specialist, QA is responsible for reviewing GMP documentation, and ensuring that commercial products and materials meet required quality characteristics. The Specialist, QA works within the QA team and alongside other departments to establish and maintain quality assurance systems necessary for ensuring operations are in compliance with current Good Manufacturing Practices, and to ensure the quality characteristics of components, in-process and finished products are met.

  • Possesses proficiency in reviewing and approving Deviations, Change Controls, Validation protocols, Method Transfers, Batch records, SOPs, and other GMP documents.
  • Performs Product Quality Complaint (PQC) investigations.
  • Provides sound quality guidance to all groups and ensures each decision maintains the Safety, Quality, Identity, Potency, and Purity (SQuIPP) of products and components.
  • Adopts and utilizes Quality Risk Management principles to make sound quality decisions.
  • Ensures the site meets all regulatory standards and consistently produces GMP compliant product.
  • Provides efficient and effective customer support to the other departments at the site and ensures compliance with and understanding of cGMPs, SOPs, and policies.
  • Provides QA expertise as a resource to identify gaps, facilitate remedial actions, and ensure issues are resolved in a compliant manner.
  • Serves as the chief QA point of contact for any assigned projects/initiatives.
  • Possesses a strong, detailed knowledge of site’s manufacturing processes and procedures.
  • Proposes solutions for issues and works with management to resolve.

Required Skills:

  • Bachelor’s degree preferred.
  • 4 years of relevant work experience required, preferably in quality assurance/quality control.
  • An equivalent combination of education, experience and training may substitute.
  • Basic knowledge of cGMP, FDA regulations, OSHA, USP and EP.
  • Ability to multi-task and be flexible.
  • Strong teamwork skills. Ability to directly contribute to the team performance and team results.
  • Ability to complete routine tasks with moderate direction, consults supervisor for advice on complex issues, confident in making decisions for minor issues.
  • Ability to follow established procedures and performs work as assigned.
  • Ability to follow directions and communicate effectively with peers, team and supervisor.
  • Ability to leverage internal relationships within function to achieve objectives with guidance.
  • Able to recognize conflict and notify management.
  • Basic writing skills, able to follow technical reports.

Working Conditions:

  • Work is generally performed seated but may require standing and walking for up to 20% of the time.
  • Work requires satisfactory completion of an eye examination to demonstrate 20/20 correctable vision.
  • Work requires satisfactory completion of a product inspection qualification.
  • Work occasionally requires uniform/PPE to work in a manufacturing, warehouse, or laboratory environment.
  • Position Handles Hazardous Materials.

This 12+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Jacqueline: