Quality Assurance AssociateBookmark This
Mountain View, CA
DescriptionQuality Assurance Associate
Location: Mountain View, CA
6 Month Contract
Perform duties in all aspects of Quality Assurance activity related to final product releases as well as assists the Quality Assurance Director/Supervisor with department needs.
1. Ensure the safe release of cellular products.
2. Ensure and promote compliance with applicable of cGMP regulations and company and client SOPs.
3. Responsible for the timely closure of Batch Records and deviation reports.
4. Responsible to support Master Batch Record Control, distribution and label verification as assigned.
5. Master Batch Record Control, distribution and label verification.
6. Assignment and maintenance of product Lot numbers.
7. Perform internal documentation audits.
8. Materials management nonconformance disposition and release activity.
9. Responsible for accurate deviation reporting and follow up actions to closures.
10. Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions.
11. Provide Quality Assurance related support to various departments.
12. Interface with suppliers and in-house product personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies.
13. Document Control activities as assigned.
14. Provide training to personnel as assigned by supervisor.
15. Meets the quality standards listed below:
A. Each employee is to practice teamwork and lateral service to create a positive work environment.
B. Each employee will understand his or her work area and Progenitor Cell Therapy goals as established in the strategic plan.
C. All employees will understand the needs of their internal and external customer so that we may deliver the service they expect.
D. Uncompromising levels of cleanliness is the responsibility of every employee.
E. Each employee will use proper telephone etiquette in representing the company.
F. Each employee is responsible to take pride and care in his or her personal appearance. All clothing and uniforms are to be clean.
G. All employees are to know their roles during emergency situations and are aware of fire and life safety response processes.
H. All employees are to notify their supervisor immediately of hazards, injuries, equipment or assistance that they may need in performing their job functions.
I. All employees are to keep proper maintenance and repair of all company equipment.
J. Protecting the assets of Progenitor Cell Therapy is the responsibility of every employee.
K. Each employee will take personal responsibility for his/her timeliness and attendance record to ensure an efficient company.
· Minimum 2-5 years related experience in the pharmaceutical or biologics industry or courses in biological sciences or equivalent.
· Excellent organizational skills and attention to detail.
· Good verbal and written communication skills.
· Strong team-oriented interpersonal skills are essential.
· Travel may be required.
· Understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs).
· Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc. a plus.
· Sound knowledge of aseptic processing and supporting technologies a plus.
· Analytical and technical troubleshooting skills are a plus.
About Kelly Services®
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions. Kelly® offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis. Serving clients around the globe, Kelly provides employment to more than 560,000 employees annually. Revenue in 2012 was $5.5 billion. Visit kellyservices.com and download The Talent Project, a free iPad® app by Kelly Services.
Our science specialty places professionals to a broad spectrum of industries, including biotechnology, chemical, clinical research, consumer products, biotechnology, consumer products, environmental, food sciences, pharmaceutical, and petrochemical fields.
Want more information? Visit kellyservices.com/science
iPad is a trademark of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc.Connect with us on ]]