Job Description

QA Associate
Job Number: 21-09536
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a QA Associate for our client in Phoenix, AZ
 
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
 
Required Skills:
  • 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
 
Responsibilities:
  • Compliance:
    • Provides sound quality guidance to all groups and ensures each decision maintains the Safety, Quality, Identity, Potency, and Purity (SQuIPP) of Client 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
  • Customer Service:
    • 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
    • Reviews and approves materials for use in commercial production
    • Support processes related to incoming materials and external suppliers.
    • Supports other departments by reviewing and approving change controls, document change controls, investigations, CAPAs, work orders, Metrology documents, and protocols in a timely manner
    • Support activities associated with Product Quality Complaints (PQC), visual inspection of product, and batch record review,
    • 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
 
Qualifications:
  • Possesses proficiency in reviewing and approving deviations, change controls, work orders, protocols, 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
  • Performs all other tasks as assigned
 
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
 
If interested, you may contact:
Chris Imbien
Chris.Imbien@eclaro.com
(843) 872-9257
 
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Application Instructions

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