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Senior QC Scientist - assay validation, method transfer

Kelly Services

Lexington, MA
Job Code:
Kelly Services
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Job Details

Job Title Senior QC Scientist - assay validation, method transfer

Jobid US41L7GT_BH1411464

Location: Lexington, MA, 02421, USA

Description **Seeking a Senior Scientist for an 12 month assignment in Lexington, MA.**

Job Description: Lead or support the execution, and data analysis of assay validation, method transfer co-qualification studies in the QC laboratories. Support completion of all protocols and validations in a timely and appropriate manner. Contribute to the evaluation of new methodologies and transfers to determine business need and applicability to the area. Perform evaluations/testing as related to improvements or project. Provide recommendations for or implement instrumentation upgrades or improvements to drive optimal performance. Author or support the writing of technical memos, reports, protocols, studies and other appropriate documentation to support laboratory validations, investigations and/or objectives. Frequent use and general knowledge of industry practices, techniques, and standards. Provide technical support to the QC Laboratories. Support global standards/strategies in continuous improvements. Comply with control of lab documentation. Review data with application of good documentation practices. Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, QSR, and cGMP regulations. Assure compliance with company procedures, quality and regulatory requirements, and regulatory guidance documents including QSR, cGMP, USP, CFR, and compendia literature. Support and implement laboratory systems and/or guidelines to meet compliance requirements. Support regulatory and non-regulatory audits e.g. Internal Quality Assessment, Corporate, FDA, etc . Support regulatory submissions /change control requests in a timely manner when required. Proactively an actively contribute to a team setting to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support. Support technical presentations and/or training to QC Laboratories including management as needed. Ensure personal training requirements are met and training records are current. Stay current in the technical and compliance field regarding lab instruments and methods. Perform Disposal of Hazardous Waste as required.


**For immediate consideration please call 732-246-0215 or email to**

**Why Kelly** **®** **?**

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect with us today.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connectwith us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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