- +1
- Pomona, California
About
Contract Duration: 6+ Months
Pay rate: Up to 25.18/hr
Location: Pomona, CA
Work Type: Onsite
Job Description:
The position of Quality Assurance Associate III is within our CMI business unit. Under the supervision of the Supervisor/Manager, the scope of this position is responsible for carry out the daily operations in the batch record department.
Job Responsibilities:
Demonstrated ability to carry out assignments in a timely, accurate manner and accomplish tasks as required with little or no supervision.
Ability to interact effectively with all levels of the organization and perform multiple tasks in a fast-paced environment.
Proficient in one or more Quality processes such as incoming inspection/change management, and/or records (including batch release). May also support some record administration and batch record review duties, including Certificate of Analysis/Certificate of Conformance creation and/or review for material lot release.
Quality Assurance Specialist works with groups within the organization to get corrections and clarifications to Device History Records.
Facilitates the Change Control process in the electronic change control system and tracks the change process through development, approval, and implementation.
Able to assist others with the Change Control process and offer guidance and best practices.
May prepare labeling for all finished products and perform labeling of products.
Analyzes and interprets the significance of the proposed changes using independent judgment to guide change initiators in the development of accurate change requests.
Reviews standard operating procedures, logs, forms, manufacturing records, work instructions, and all other Quality records for adherence to established templates, good documentation practices, and adequacy of referenced procedures and part numbers.
Utilize the database to perform transactions and verify product information.
Generate and/or review Certificate of Conformance/Certificates of Analysis for Final Product.
Filing of records.
Communicates issues effectively and partners with cross-functional associates to meet compliance requirements.
Can leverage collaboration and help to drive organizational improvements with compliance issues.
Able to troubleshoot issues and improve systems as needed.
Can coach staff in real-time to resolve issues and improve future outcomes.
Works on complex assignments, where considerable judgment and initiative are required in resolving problems and making recommendations.
Knowledgeable of federal and other regulations, e.g., QSRs, ISO 13485, CMDR, etc.
Understands and is aware of the quality consequences that may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing, and testing activities.
Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices; build productive internal/external working relationships.
Carries out duties in compliance with established business policies.
Other duties as assigned, according to the changing needs of the business.
Minimum Qualifications | Education/Experience:
High School Diploma or GED.
3-5 years of related experience.
Experience with MS Office.
Able to work on multiple tasks as a team member and/or able to operate as an individual contributor.
Must be detail-oriented, self-motivated, and available for flexible scheduling
Strong communication, problem-solving, and motivational skills.
Preferred qualifications:
Bachelor's Degree.
Working knowledge of Quality Assurance in a medical device manufacturing environment, preferably in-vitro diagnostic.
Knowledge of Quality System Regulations.
Job Competencies:
High level of attention to detail
Teamwork
Communication
Strong organizational skills
Initiative
Adaptability
Benefits:
Medical, Vision, and Dental Insurance Plans
401k Retirement Fund
About the Company:
Global Healthcare Innovator
We're a leading healthcare company dedicated to improving lives worldwide. Our diverse portfolio includes medical devices, diagnostics, nutrition products, and branded generics. We're committed to developing groundbreaking technologies that address critical healthcare challenges and empower people to live healthier lives.
Join our team and:
Work on cutting-edge projects
Contribute to global healthcare advancements
Experience diverse cultures and geographies
Discover a rewarding career with a company that cares.
About GTT:
GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. As a Native American-owned, economically disadvantaged corporation, we highly value diverse and inclusive workplaces. Our clients are Fortune 500 banking, insurance, financial services, and technology companies, along with some of the nation’s largest life sciences, biotech, utility, and retail companies across the US and Canada. We look forward to helping you land your next great career opportunity!
25-23153: #gttic #gttjobs
Work experience
- QA
Languages
- English