Job Details

  • Title: QA Associate
  • Code: RCI-37091-1
  • Location: Phoenix Arizona (AZ) 85043
  • Posted Date: 04/07/2021
  • Duration: 12 Months

  Job Description

Knowledge, Skills, and Abilities

  • Basic knowledge of cGMP, OSHA, USP and EP
  • Ability to multi-task and be flexible
  • Strong teamwork skills
  • Ability to complete routine tasks with moderate direction; consults supervisor for advice on complex issues, confident in making decisions for minor issues
  • Ability to directly contribute to the team performance and team results
  • 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

Duties and Responsibilities

  • Provides sound quality guidance to all groups and ensures each decision maintains the Safety, Quality, Identity, Potency, and Purity (SQuIPP) of Celgene products and components
  • Adopts and constantly 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
  • Works with Plant Operations to ensure compliance with and understanding of cGMPs, SOPs, and policies
  • Supports other departments by reviewing and approving change controls, document change controls, investigations, CAPAs, work orders, Metrology documents, and protocols in a timely manner
  • Performs routine visual inspections of product (required for every lot produced)
  • Reviews and approves materials for use in commercial production
  • Reviews batch records and assists in release of finished product from the facility
  • Provides QA expertise as a resource to identify gaps, facilitate remedial actions, and ensure issues are resolved in a compliant manner
  • Possesses proficiency in reviewing and approving deviations, work orders, reports, batch records, and other GMP documents
  • Possesses a strong, detailed knowledge of site's manufacturing processes and procedures
  • Proposes solutions for issues and works with management to resolve
  • Actively contributes towards team goals with guidance