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19 days old

Biopharmaceutical QC Project Lead â?? Houston, TX

Kelly Services
Houston, TX 77007
**_Biopharmaceutical QC Project Lead Houston, TX_**



Kelly Scientific Resources is currently seeking a QC Project Lead for a Biopharmaceutical company in Houston, TX. In this role, the QC Project Lead will lead the introduction of new methods and processes into the Quality Control (QC) department via the technology transfer process, represent the department on project teams, and provide technical support during investigations.



**Job Responsibilities:**




+ Participates in the initial assessment of new products and processes.

+ Provides input to program management regarding QC capabilities and requirements for method qualification/validation.

+ Provides technical review of Statements of Work (SOWs) to support contract manufacturing activities.

+ Provides QC representation to project team meetings.

+ Responsible for relaying pertinent information such as production schedules and information requests to applicable QC groups.

+ Writes, reviews, and/or approves Test Records/Forms, Sampling Plans, and Specifications.

+ Leads tech transfer activities related to QC including generation of a QC master transfer plan, method specific assay transfer protocols and reports, training plans, and project timelines.

+ Assists with QC procurement, setup, and validation activities for new equipment and materials required to support new methodology.

+ Assists with responses to audits, deviations, out of specification (OOS) investigations, and corrective/preventative actions (CAPA).



**Job Requirements:**




+ Bachelors degree in a Science discipline

+ 5-10 years of relevant experience

+ Experience with method validation and technology transfer required.

+ Knowledge of biological cell based assays such as proliferation/cell count and viability, flow cytometry, ELISA, and PCR preferred.

+ Prior experience working with cell or gene therapy products a plus.

+ Able to develop and deliver training programs for specialized and advanced activities.

+ Aids in development of training plans and identification of training gaps.



This is a temp to hire position with a work schedule of Monday through Friday, day shift. Pay rate for the position is commensurate upon level of applicable experience. If you meet the above qualifications, please submit your resume for immediate consideration.






**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: 2019-10-28 Expires: 2019-11-28

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Biopharmaceutical QC Project Lead â?? Houston, TX

Kelly Services
Houston, TX 77007

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