Kelly is hiring a Quality Systems Specialist for one of our biotech clients in West Hills, California.
Hours of Shift: 8am to 5pm M-F pay rate: $30.00 4 month contract
Quality Systems Specialist
The Quality Systems Specialist will monitor/address/track quality issues that arise from nonconformance, supplier corrective actions, or from Internal/External quality system audits.
This position will assist the QA Supervisor and product line/QS process owners with Corrective/Preventive action (CAPA) projects to ensure timely and effective completion of required activities.
The duties and responsibilities include, but are not limited to the following:
Responsible for determining non-conforming products and materials disposition (implementing QA quarantines and/or release of affected inventory).
Gathers information from multiple departments (Customer Service, Product Specialists, Product/Process Owners and Regulatory) in order to assist RA and process owners with the determination of risk related to a reported Nonconformance.
Responsible for the assignment of CAPA reports (corrective/preventive action
requests) and SCAR reports (supplier corrective action reports).
Ensure all nonconforming product(s) are identified and removed from use.
Ensure completion and accuracy of all associated quality records related to nonconformance and CAPA/SCAR reports.
Assist with the performance and documentation of Internal Audits and support External Audits, as required.
Lead and/or participate in product related team meetings and/or performance reviews, as needed.
Assist with QA department functions as needed.
(Specific duties may vary and will be documented in department records, job assignments and/or project action items).
Perform computer operations for data entry and provide tracing/trending reports.
Additional support of routine QA department standard operating procedures (SOPs) is also expected when necessary.
Minimum Qualifications:
Bachelor’s degree in Biological Sciences or a related field
Two (2) years of experience in a Quality regulated environment
Familiarity with creating presentations, work with spreadsheets, prepare reports and write procedures utilizing MS Word, Excel and PowerPoint software applications
Preferred Qualifications:
Background in diagnostics
Knowledge of:
Detailed knowledge of ISO and GMP regulations which govern a medical device and diagnostics manufacturing.
Familiarity of statistical process controls GMP CAPA requirements.
Tracking and trending tools and reporting techniques.
Ability to:
Provide accurate QS tracking and trending reports.
Good procedural writing skills a plus.
Exercise independent discretion and judgment in execution of duties.
Plan and organize oneself in a consistent manner.
Be a self-starter with the ability to positively motivate others in a cooperative fashion.
Establish and maintain effective working relationships with other staff members.
Effectively communicate both orally and in writing to management, customers and regulatory personnel.
Maintain confidentiality of sensitive laboratory information; perform computer operations for data entry.
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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/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?).
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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity.
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