22 days old

Senior Manager, Quality Control - Carlsbad, CA

Kelly Services
Carlsbad, CA 92008
Senior Manager, Quality Control - Carlsbad, CA

This person will be responsible for managing the quality control function for 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).

Duties & Responsibilities:

- Coordinate quality control 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

- 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


- 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

- Experience in similar function in an organization with multiple commercial product

Education & Experience:

- Bachelors degree or higher in a scientific discipline

- Minimum of 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 quality control experience is a plus

**For immediate consideration apply today!**

**Questions? Please reach out to Dustin at**

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

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits 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, 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
Posted: 2020-07-17 Expires: 2020-08-17

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Senior Manager, Quality Control - Carlsbad, CA

Kelly Services
Carlsbad, CA 92008

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