Quality Specialist Job Listing at Kelly Services in CA (Job ID 9353087)

Description

Quality Control Technician

The Quality Specialist will maintain quality assurance programs, procedures and controls, ensuring that finished devices are inspected and/or reviewed to ensure they meet medical device requirements and are of the highest quality standards prior to release for sale. This role will also be responsible to ensure that sophisticated device history records DHR are maintained in an organized manner and able to be assembled quickly for audit purposes.

Key Responsibilities:

• Perform product inspections as required to ensure conformance to specifications
• Review label submissions as required and produce labels to ensure conformance to specifications
• Review of production, packaging/labeling and laboratory documents for final product release Assemble device history records
• Systematically release finished and semi-finished product based on conformance to established standards
• Scan and/or prepare DHRs for Archive and offsite scanning and ensure legibility and accuracy of electronic storage
• Participate in Non-Conformance and CAPA investigations and help to develop solutions to system and procedural problems
• Maintain ownership of SOPs and train colleagues on SOPs as needed
• Generate, identify, and suggest quality/process improvements
• Assist writing as well as assist others in writing new or updated operating procedures and/or work instructions
• Assist in document preparation/presentation for regulatory agency visits and Corporate/internal audits.
• Provide real-time support to Product Packaging to prevent backorder, non- conforming materials release and adherence to the production schedule.
• Under limited supervision and in accordance with all applicable federal, state and local laws/regulations, the Companies policies, procedures and guidelines,
• The Product Release Specialist Engineer I, QA will ensure quality and compliance and safety in all their actions.
• Complete all required trainings in a timely manner.
• Attend GMP training as appropriate for the role.
• Adhere to strict compliance with procedures applicable to the role. 
• In a timely and prompt manner, identifies, reports, and seeks correction for deviations noted in the workplace.
• Practice all behaviors in a safe and environmentally responsible manner.

Minimum Requirements:

• A minimum of a High School Diploma is required; Bachelor s Degree in Life Sciences is preferred.
• A minimum of 3+ year s related QA or QC experience required, experience in a GMP regulated environment is preferred.
• Previous experience reviewing and releasing batch records is also preferred.
• Excellent analytical, prioritization, multi-tasking and communication is required.
• Strong leadership skills and the ability to work independently without supervision are required.
• The ability to prepare and present written and verbal reports is also preferred

Exact Schedule - 8am -5pm M-F fully onsite 

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

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