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1+ months

Quality Assurance Manager, Carlsbad, CA

Kelly Services
Carlsbad, CA 92008
**Quality Assurance Manager, Carlsbad, CA**



The Quality Assurance Manager assists in the development, implementation and management of Quality Assurance program and initiatives across company (Proteomics, ImmuneCarta and Diagnostics). Conducts internal and external audits to assess compliance with regulations and company's policies and procedures. Serves as Quality / GxP resource for supporting company's cross-functional project teams.



**Job Duties and Responsibilities:**




+ Assist in the development, implementation and maintenance of the Quality System and associated procedures.

+ Update and maintain Quality Assurance logs and databases, and generate metrics as needed.

+ Coordinate activities for routing QA documents for review and/or approval.

+ Provides GxP compliance and general QA support to internal teams as needed.

+ Conducts internal and external audits, as needed.

+ Reviews SOPs to ensure compliance with applicable regulatory and corporate standards.

+ Develop and write SOPs.

+ Participates in the development and delivery of internal training programs.

+ Assists management in the preparation for regulatory agency inspections as well as client specific inspections.

+ Review and evaluate CAPAs associated with non-conformances and audit observations.

+ Review CAPAs to determine effectiveness, perform CAPA trend analysis and compile summary reports.

+ Involved in the recruitment of QA auditors and management of QA auditors.

+ Keeps up to date with current regulatory guidelines and regulations.

+ Communicate compliance risks to senior management

+ Performs other duties as assigned.



**Job Requirements:**




+ Bachelor's degree (BA/BS)

+ 5 years of quality and/or compliance related experience in the pharmaceutical / diagnostic industry

+ Should have demonstrated knowledge and experience in the application of US Code of Federal Regulations (CFR) in relation to Good Laboratory Practice (GLP) or CAP or CLIA

+ Ability to work well in a team environment

+ Strong commitment to the accomplishment of tasks

+ Has the initiative to identify opportunities for improvements and inter-personal skills to promote and accomplish constructive solutions to problems

+ Self-motivated, focused and persistent. High level of attention to detail and accuracy Excellent organizational, problem-solving and communication skills

+ Ability to prioritize work and handle multiple assignments, while maintaining quality

+ Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner

+ Excellent investigative techniques

+ Employee is personally responsible for following Health and Safety Guidelines



**For Immediate Consideration, Apply Today! Questions?** **Call Grace at 714-971-0721 or Email at grace.piper@kellyscientific.com**






**Why Kelly** **** **?**



With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 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 careerconnect with us today.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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. 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. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2019-08-02 Expires: 2019-10-21

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Quality Assurance Manager, Carlsbad, CA

Kelly Services
Carlsbad, CA 92008

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