Job Title: Quality Assurance Associate III
Location : Pomona, CA, 91767
Duration : 06 Months
Shift: 8:00 AM โ 5:00 PM
Job Summary
Under the supervision of the Supervisor/Manager, this position is responsible for carrying out daily operations in the Batch Record Department and supporting quality system processes.
Responsibilities
- Carry out assignments in a timely and accurate manner with little or no supervision.
- Interact effectively with all levels of the organization and perform multiple tasks in a fast-paced environment.
- Support Quality processes including incoming inspection, change management, records administration, and batch release.
- Support batch record review and Certificate of Analysis (COA) / Certificate of Conformance (COC) creation and review for material lot release.
- Work with internal groups to obtain corrections and clarifications to Device History Records (DHR).
- Facilitate the Change Control process through development, approval, and implementation.
- Assist others with Change Control processes and provide guidance and best practices.
- Prepare labeling for finished products and perform product labeling activities.
- Analyze and interpret proposed changes and guide change initiators in developing accurate change requests.
- Review SOPs, logs, forms, manufacturing records, work instructions, and other quality records for compliance and documentation accuracy.
- Utilize databases to perform transactions and verify product information.
- Generate and/or review Certificates of Conformance and Certificates of Analysis for final products.
- File and maintain quality records.
- Communicate issues effectively and collaborate with cross-functional teams to meet compliance requirements.
- Support organizational improvements related to compliance issues.
- Troubleshoot issues and improve systems as needed.
- Coach staff to resolve issues and improve future outcomes.
- Work on complex assignments requiring judgment, initiative, and problem-solving.
- Maintain knowledge of applicable regulations including QSRs, ISO 13485, and CMDR.
- Perform duties in compliance with established business policies.
- Complete other duties as assigned.
Minimum Qualifications
- High School Diploma or GED.
- 3โ5 years of related experience.
- Experience with MS Office.
- Ability to work on multiple tasks independently and as part of a team.
- Detail-oriented and self-motivated.
- Strong communication, problem-solving, and motivational skills.
- Available for flexible scheduling.
Preferred Qualifications
- Bachelorโs Degree.
- Working knowledge of Quality Assurance in a medical device manufacturing environment, preferably in-vitro diagnostics.
- Knowledge of Quality System Regulations.