Quality Analyst I, Medical Device, Irvine, CA

Quality Analyst I, Medical Device, Irvine, CAScope and Purpose of PositionThis position supports the Quality Management System and QA Product Release Group.Responsibilities

Support the implementation and maintenance of an efficient system for reviewing and releasing finished product.

Provide support for the QA Complaint system for all product lines. Duties include the receipt and Investigation of complaints, correspondence with internal/external customers and with RA/QC.

Perform and coordinate QA documentation system. Assist in the review and modification of different manufacturing procedures and documents as part of continuing process improvements.

Provide in-process support in the manufacturing of all Alliance Medical Products saleable products.

Receive, sample and analyze appropriate samples for the release testing of raw materials and in-process materials. Perform the QA testing on all applicable AMP, FDA, USP, NF, CFR and other standards.

Maintain protocols and final report files, reserve samples, product complaints and batch records.

Perform validation testing to support the release of raw materials, in-process materials and finished product. Execute protocols to support the validation of new equipment and products.

Review all notebooks and summary reports for accuracy, completeness and compliance to relevant procedures and standards.

Communicate with laboratory personnel/manager to correct and improve deficiencies in data collection, analysis and reporting.

Investigate laboratory deviation or systemic problems to identify root cause and effective corrective and preventive actions.

Required Knowledge, Skills and Abilities

Working knowledge of QA/QC principles

Knowledge and training in GMP/GLP/ISO guidelines.

Good computer skills

Strong attention to detail

Good oral and written communication skills

Required Education and Experience

BS degree in Biochemistry, Chemistry, Engineering, Biology or closely related discipline required

2 + years’ experience in Quality Assurance / Manufacturing environment

For Immediate Consideration, Apply Today! Questions? Call Grace at 714.253.7656 or schedule a time to connect directly follow the link: https://calendly.com/gracepiper/15min-1Why Kelly ® ?Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly ®At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.