Quality Assurance Associate/QC
INTELLECTT INC
- Pomona, California, United States
- Pomona, California, United States
Über
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.
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Sprachkenntnisse
- English
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