Quality Assurance Specialist

3 weeks ago

West Sacramento, California, United States Gemini Bio-Products Full time
Overview

Gemini Bio-Products is a leading provider of cell culture products, instruments, and solutions to the global biotechnology industry. With a focus on quality and customer satisfaction, we are seeking a highly motivated and detail-oriented Quality Assurance Associate I to join our team.

The successful candidate will be responsible for ensuring compliance with cGMP regulations and company procedures, while also supporting the development and implementation of quality management systems. This role requires strong analytical and communication skills, as well as the ability to work effectively in a fast-paced environment.

Salary: $65,000 - $85,000 per year, depending on experience.

About the Job

We are looking for a talented Quality Assurance Associate I to support our quality management systems and ensure compliance with regulatory requirements. In this role, you will:
  • Maintain up-to-date knowledge of cGMP (21 CFR Part 820) and ISO13485:2016 regulations, industry and affiliated publications, standards, and guidance.
  • Review departmental completed records to ensure compliance to all associated procedures.
  • Review completed manufacturing and development Device History Records prior to product release.
  • Assist procurement department with purchasing by ensuring purchasing material meets Final Product Specification/Raw Material Specification.
  • Support and maintain the Supplier Management Program.
  • Initiate and track requests for document changes, deviations, non-conforming material records, change controls, CAPAs, and complaints for product and material-specific events.
  • Assign company-wide training in training software.
  • Initiate and perform quality events (deviations, CAPAs, risk assessments, non-conformances, etc.) for the Quality Assurance Department.
  • Create Quality documents such as Certificate of Analysis, Certificate of Origin, and TSE/BSE statements as needed.
  • Maintain an organized filing system of controlled documents, logs, complete Device History Records, guidance documents, and all other documents required by applicable regulations.
  • Support internal audits and onsite audits of the facility.
  • Manage equipment calibration and preventative maintenance schedules to ensure the most up-to-date status is readily available.
  • Ensure all required documents for an associated asset are properly tracked, stored, and valid for use.
  • Work and communicate effectively across departments to implement QMS improvements and to maintain its effectiveness.

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