Quality Assurance Associate/QC

Job Title: Quality Assurance Associate III

Location : Pomona, CA, 91767

Duration : 06 Months
Shift:8:00 AM 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.
• 3 5 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

• Bachelor's Degree.
• Working knowledge of Quality Assurance in a medical device manufacturing environment, preferably in-vitro diagnostics.
• Knowledge of Quality System Regulations.