Kelly Services Stability Coordinator in Irvine, California
Stability Coordinator - Irvine, CA
Salary rate: $19-21/hr DOE
PRIMARY DUTIES AND RESPONSIBILITIES:
Coordinates the Stability Program’s full cycle by preparing mandated reports, labeling, organizing, storing and pulling stability retains. Coordinate and oversee the filing of all stability protocols and laboratory reports in compliance with Standard Operating Procedures.
Coordinate collection of finished goods samples for all new and revised products to ensure that stability studies have been carried out in accordance with GMP or standards equivalent to GMP guidance.
Ensure that all necessary QC testing and inspection have been performed, including additional sampling, inspections, tests or checks initiated because of deviations or planned changes.
Maintain the log for stability studies to ensure that all existing products (nutritional, drug & OTC) are placed on stability as specified by protocol or SOP by assigning their appropriate test dates for RT, AT, and IT.
Prepare, write and coordinate stability protocol for specific products.
Prepare regression analyses for all stability products as specified by protocol or SOP.
Maintain and enter data for the finished testing into the stability database.
Maintain the organization of the stability room, temperature room, and accelerated chamber.
Coordinate routine stability tasks to ensure completion as needed.
Prepare, review, and file stability laboratory reports and summary reports after completion of the study.
Perform technical reviews of test results performed by QA technicians and QC Chemists.
Keep track of all active projects and provide monthly updates regarding discrepant results to the marketing, R&D, and QA teams.
Responsible for general filing maintenance of all stability related documentation.
Maintain knowledge and experience up to date in light of technical and scientific progress and changes in quality management relevant to the products.
Other special projects or responsibilities as assigned.
Bachelor’s degree in a scientific discipline.
Experience in a quality control or quality assurance function associated with pharmacutical manufacturing preferred.
Possess clear verbal and written communication abilities to read, analyze, and interpret government regulations, write clear reports and effectively present information and respond to questions from supervisor, clients or regulatory agencies.
Possess methodical organizational skills.
Ability to work in a team structure where cooperation is crucial to success.
Solid working knowledge of creation and management of documents in Microsoft Excel, and Word program.
Ability to understand and apply concepts of basic algebra and statistics.
Ability to interpret a variety of instructions furnished in written, verbal, diagram, or schedule form.
If you meet the above qualifications, please submit your resume for immediate consideration. Questions? Please call Airika at 562-206-2707
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 9,000
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 2017 was $5.4 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.