Sr. Quality Assurance Technician
Kelly® Science & Clinical is seeking a Sr. Quality Assurance Technician for a contract-to-hire position at a cutting-edge client in Corona, CA. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Pay: $35/hour
Schedule: Monday–Friday, 8:00 AM–5:00 PM (1st shift) Onsite
Overview
Reporting to the Quality Assurance (QA) Manager, the Senior Quality Assurance (QA) Technician is responsible for assisting the facility QA Manager in ensuring the quality system requirements are met and maintained. This role assists in providing management with information and data analysis on all key aspects of daily quality related metrics to the operation, which is used by both facility and corporate management to determine if the quality system is adequate and operating as designed. This information and data is also used to provide guidance for corrective actions and continuous improvement.
The Senior QA Technician will assume additional responsibilities over those assigned to the QA Technician, including representing our Client in customer audits (as assigned), completing investigations, risk assessments, and other quality system related activities as identified and assigned by the facility QA Manager. The Senior QA Technician must effectively interface with facility personnel, corporate staff, and customers.
Responsibilities:

• Provides information and data analysis reflecting the status of the plant quality system
  

• Completes inputs and trend analysis for monthly review of the Total Quality Management Report
  

• Performs quality data analysis for Management Review
  

• Performs investigations, root cause, and risk assessment for deficiencies; documents findings in the electronic quality control management system (MERLIN)
  

• Assists with corrective action, preventive action, and effectiveness verification action plans
  

• Conducts monthly CAPA meetings
  

• Issues release of processed products, including processing runs that require review for possible deficiencies
  

• Authorized to remove product from Hold status
  

• Serves as an Administrator for the electronic training management system (LMS)
  

• Manages the calibration/verification of instruments and calibration reviews/approvals in the electronic asset management system (EAM) for maintenance and calibrations
  

• Completes facility document change requests in the electronic quality control management system (MERLIN) and procedure translations, if applicable
  

• Assists in all activities relevant for FDA, customer, and regulatory audits
  

• Representative in customer audits, as assigned by the QA Manager
  

• Completes expert user training in one electronic management system in use at the facility (e.g., E1, SADA KonnTRACK, LMS Administrator, VeriCycle)
  

• Performs the responsibilities and duties of the Quality Assurance Technician (if the position does not exist at the facility)
  

• Serves as Deputy to the facility QA Manager, as needed
  

• Other Quality Assurance / Validation (if applicable) duties as assigned

Gamma & E-Beam Technology

• Performs data gathering and analysis for new customer products
  

• Assists with / completes applicable tote loading diagrams and PQ documentation
  

• Assists the QA Manager in calibration of dose measurement systems

Qualifications:

• Bachelor’s Degree or a minimum of 5 years of experience working in a quality / medical device / sterilization / pharmaceutical environment preferred
  

• Ability to read, write, and speak fluent English
  

• Experience owning CAPA investigations
  

• Proficient using a computer and able to analyze data in a database/spreadsheet

What happens next:
Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.

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