Quality Assurance Specialist

Our client, a leading organization in the quality assurance sector, is seeking a Quality Assurance Specialist to join their team. As a Quality Assurance Specialist, you will be part of the quality control department supporting various teams. The ideal candidate will have strong analytical skills, attention to detail, and excellent communication abilities which will align successfully in the organization.

Job Title: Quality Assurance Specialist

Location: Pomona, CA

Pay Range: $24- $25 /hr on w2

Responsibilities:

• Demonstrated ability to carry out assignments in a timely, accurate manner and accomplishing 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, and/or 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.
• Work 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 Change Control process and offer guidance and best practices.
• May prepare labeling for all finished product and perform labeling of product.
• 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 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.
• Is able to leverage collaboration and helps to drive organizational improvements with compliance issues.
• Able to troubleshoot issues and improve systems as needed.
• Is able to coach staff, in real-time, to resolve issues and improve future outcomes.
• Works on assignments that are complex in nature 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 which 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.

Key Success Factors:

• Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor.
• Must be detail-orientated, self-motivated and available for flexible scheduling
• Strong communication, problem solving and motivational skills.

 Qualifications:

• High School Diploma or GED required. Bachelor’s degree preferred.
• 3-5 years of related experience.
• Experience with MS Office.
• Working knowledge of Quality Assurance in a medical device manufacturing environment, preferably in-vitro diagnostic is a plus.
• Knowledge of Quality System Regulations a plus.

Upon completion of waiting period consultants are eligible for:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Dependent Care Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long Term Disability Insurance
• Business Travel Insurance
• 401(k), Plus Match
• Weekly Pay

If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

About ManpowerGroup, Parent Company of:  Manpower, Experis, Talent Solutions, and Jefferson Wells

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2023 ManpowerGroup was named one of the World's Most Ethical Companies for the 14th year - all confirming our position as the brand of choice for in-demand talent.