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Job Title: Quality Control Supervisor
Supervises all aspects of the Quality Control area with minimum if any supervision, handles routine functions independently as well as assists the Senior Director of Quality Assurance/Quality Control with department needs.
1. Hire, develop, and evaluate QC personnel.
2. Train and supervise QC analysts to various procedures such as limited to flow cytometry, CBC, endotoxin testing, sterility test reading, equipment/instruments such as the AcT Diff, Microplate reader, FACS, microscope and to client projects and SOPs.
3. Supervise and oversee QC personnel in their role for safe and efficient verification, approval, release/disposition of Company or client products/ materials.
4. Ensure and promote compliance with applicable cGMP and GTP regulations and company and client SOPs.
5. Able to use knowledge and experience in demonstrating judgment and decision making process.
6. Assist in investigation and root cause analysis and oversee timely closure of deviation reports and applicable batch records.
7. Ensure completion and oversee review of QC logs.
8. Responsible for the completion of all client QC requirements related to GMP cellular product and/or material.
9. Maintain good client relationship.
10. Oversee QC associates role in material disposition via deviation reporting system or client based system if applicable.
11. Prioritize, schedule and manage multiple projects and resources simultaneously.
12. Monitor effectiveness of quality systems, change control activities and completion, both facility and client specific.
13. Evaluate and investigate customer complaints and deviations; initiate and coordinate corrective and preventive actions as they relate to the quality control function or as assigned.
14. Maintain tracking and trending aspects of the deviation reporting system.
15. Provide training to personnel as required.
16. Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies as applicable.
17. Interface with operation?s management and upper management in significant deviation resolution and corrective action implementation.
18. Develop, revise and implement Standard Operating Procedures as related to Quality Control activities.
19. Complete projects and special tasks as assigned by supervisor.
20. 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 Company 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 and notify their supervisor of any issues.
J. Protecting the assets of the company 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.
L. All employees will sign and adhere to the Company?s Confidentiality Agreement.
Assumes other responsibilities as assigned.
About Kelly Services ®
- Minimum 5 years related experience in the pharmaceutical, biologics or related industry.
- BS Degree in biological sciences or equivalent.
- Minimum 3 years QC supervisory experience is required.
- Understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs).
- Working knowledge of routine QC laboratory procedures such as flow cytometry and CBC analysis, endotoxin testing, equipment and systems, an understanding of production processes, validation, etc. Sound knowledge of aseptic processing and supporting technologies.
- At least 3 years experience with writing, reviewing and following Standard Operating Procedures.
- Analytical and technical troubleshooting skills are a plus.
- Excellent organizational skills and attention to detail.
- Good verbal and written communication skills.
- Strong team-oriented interpersonal skills are essential.
- Travel may be required.
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
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Kelly Services - 13 months ago
Kelly Services, Inc. (Kelly) is a global temporary staffing provider operating in 36 countries and territories throughout the world. The...