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1+ months

Senior Manager, Quality Control (QC), Carlsbad, CA

Kelly Services
Carlsbad, CA 92008
**Senior Manager, Quality Control (QC), Carlsbad, CA**



We are seeking a Senior Manager, Quality Control (QC) to join our analytical team! This person will be responsible for managing the quality control function for company's commercial products. This individual will be primarily responsible for managing and overseeing the release of all raw materials, in-process tests, release and stability testing for all drug product batches at various Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs). This position reports to the Director, Product Development.



**Essential Duties and Responsibilities:**




+ Coordinate analytical testing activities for raw material, in-process sample and drug product release and stability

+ Monitor reference standard inventory and availability

+ Review, monitor and implement USP monograph changes impacting our product

+ Generate and approve Certificate of Analysis for raw material and drug product

+ Draft, review and approve stability protocols and reports

+ Review and trend stability data

+ Review and approve test methods and specifications related to change controls

+ Help with troubleshooting analytical method related issues at CMOs / CROs

+ Review and mitigate laboratory investigations

+ Support regulatory and quality teams with the preparation and review of annual product reviews

+ Review and approve quality agreements

+ Support Quality and Regulatory audits of CMOs / CROs as a subject matter expert

+ Support Manufacturing and Supply Chain functions to establish quantities and a sampling process of drug substance, components and drug products at the CMO and CROs

+ Renew contracts with CROs

+ Support lifecycle programs

+ Other duties as assigned or required.



**Job Requirements:**




+ Bachelor's degree (BS) or higher in a scientific discipline

+ Ten (10) years of experience in chromatographic methods, data review and data systems working in a cGMP regulated environment

+ Minimum two (2) years of experience working with third party vendors

+ Generic Injectable QC experience is a plus

+ Strong communication, analytical and technical writing skills

+ Exceptional attention to details, organizational skills, including the ability to prioritize and multitask in a fast-paced, project driven environment

+ Proficiency in the use of Microsoft Word, Excel and Outlook

+ Strong knowledge of the Food and Drug Administration (FDA) pharmaceutical drug development process and phase appropriate Good Manufacturing Practice (GMP) compliance requirements

+ Experience in supporting stability programs for drug product

+ Experience in outsourcing and working with third party vendors across the globe



**For immediate consideration, apply today! Questions? Contact Dustin at 858.207.6311, or email dusg877@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: 2019-08-23 Expires: 2019-11-09

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Senior Manager, Quality Control (QC), Carlsbad, CA

Kelly Services
Carlsbad, CA 92008

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