Kelly Services Quality Assurance (QA) Specialist III, Oceanside, CA in Oceanside, California
Quality Assurance (QA) Specialist III, Oceanside, CA
We have an exciting opportunity for a Quality Assurance (QA) Specialist III with a market leader in in the Life Science industry located in Oceanside, CA.
The Quality Assurance Specialist III is a crucial role in conducting all aspects of Quality Assurance (QA). As a QA Specialist III, you will be responsible for managing, coordinating, facilitating and implementing quality assurance standards based on ICH and ISO requirements across all products. The incumbent in this position directs quality assurance methods, develops and controls quality programs, monitors production conformance with QA standards and procedures as well as participates in creating methods for improving product quality.
Essential Duties and Responsibilities:
Participate in the development, implementation, management and integration of a Quality Management System (QMS) for all production activities and products.
Serve as the primary quality control resource for problem identification, resolution, loss reporting and continuous improvement.
Review and release the regulatory document packages (including batch record, CoA and other related documents) for each product lot.
Participate in the design, implementation and documentation of procedures for process control, process improvement, testing and inspection.
Maintain metrics (process capability, control charts, measurement quality) for monitoring system effectiveness and to enable managers to make sound product quality decisions.
Perform root-cause analysis and other problem solving activities to identify effective corrective actions and process improvements.
Maintain collection and analysis systems of statistical data to predict trends that will affect improvement of product quality.
Assist in process validation activities.
Review customer purchase orders, contracts and change requests and ensure that the necessary criteria and provisions are included in quality and process plans.
Report to management on quality issues, trends and losses.
Review suppliers purchase orders and establish supplier quality requirements.
Participate in internal and external quality audits.
Interface with supplier and customer quality representatives concerning problems with quality control and assure that effective corrective action is implemented.
Other duties as assigned or identified.
Bachelor's degree in Science field.
Three (3) to five (5) years of experience in cGMP in a biotech or pharmaceutical environment.
Manufacturing QA experience
Batch record review
Working closely with QC department (reviewing forms/procedures, and data)
Writing procedures/ Revising SOPs
Experience with Quality Systems (procedures, regulatory, QA functions, able to use Microsoft)
Strong technical writing ability
Knowledge of US and European Pharmaceutical regulations for early stage product, including GLP, GCP and GMP
Strong organizational skills, task oriented, excellent time management skills
Ability to multi-task; flexible and adaptable to changing priorities
Works well with limited supervision and as a team member
Effective communicator. Demonstrate the ability to negotiate assigned tasks with staff
Lifting up to 50 pounds may be required.
APPLY TODAY. QUESTIONS? Call Kevin at 602.548.1774
Why Kelly ® ?
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm