Quality Assurance Specialist
6 days ago
Job Description
The MRB Coordinator, colloquially known as the Quality Engineer, plays a vital role in site communication and timely completion of actions. This position involves tracking and trending Quality Events, Cause Investigations, and CAPAs to ensure compliance with standards.
Duties/Responsibilities:
- Perform all work in accordance with company quality procedures and standards.
- Maintain compliance of Quality System elements applicable to the site/function.
- Evaluate Quality Events for impact and trending.
- Investigate product failures for deviations, technical customer complaints, and CAPAs.
- Back up the Complaint Coordinator position.
- Support the validation process from the Quality perspective.
- Maintain compliance to quality standards for all new and existing products.
Qualifications/Experience:
- Bachelor's degree in Biology, Chemistry, or Engineering.
- Minimum 3 years of relevant industry GMP experience (preferably in Quality).
- One year of engineering or investigative experience.
- Experience with GMP systems regulated by ISO or government agencies.
- Knowledge or experience with risk management.
- Advanced technical writing skills.
- Strong leadership and communication skills.
- Experience with Microsoft suite and TrackWise Digital.
- Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) desired.
Estimated Salary:$120,000 - $150,000 per annum based on location and experience.
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