CenterWatch

26 days old

Scientist - Senior

Kelly Services
Lexington, MA 02421
Kelly Services is currently seeking a Scientist - Senior in Lexington, MA to work a contract assignment of 6 months for one of our top clients. Kelly is a full service workforce solutions provider to 98% of the Fortune 100 companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.



**Primary Responsibilities of the** Scientist - Senior **includes:**




+ Expertise and technical leadership managing product testing, method validations/transfer, investigations, CAPAs, change requests, and deviations.

+ Manage assay transfer and/or validation activities for QC, including authoring and/or reviewing protocols, coordinating testing with CTLs, performing statistical data analysis and final summary reports per ICH and Shire internal guidelines.

+ Lead investigator providing technical and analytical representation for QC on investigation teams, with strong understanding of compliance and cGMP's, strong scientific judgment and leadership in decision making.

+ Coordinate analytical support within QC necessary to identify root cause.

+ Facilitate investigations, review of process and method validation initiatives in support of the QC laboratories in the resolution of OOS investigations.

+ Provide technical expertise and support for troubleshooting and assay remediation.

+ Manage and contribute to cross functional teams to close investigations, determination of root cause, and implementation of appropriate CAPAs.

+ Lead management of the document change requests for method SOPs.

+ Works on problems of diverse scope in which analysis of situation or data requires evaluation of identifiable factors.

+ Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

+ Technical Program/project Management (35%)

+ Technical writing-author and review of protocols, reports, data summaries, procedures, LIMS etc. (25%)

+ Support investigations of product deviations (25%)

+ Work with QC, QA, Supply Chain, Analytical Development, Process Development, Manufacturing, Technical Services, Regulatory Affairs, CTLs and CMOs (15%).

+ Key Skills, Abilities, and Competencies: Direct experience within GMP organizations, experience in Quality preferred; Excellent, professional interpersonal and communication skills (both verbal and written); Demonstrated ability to work effective by independently and on cross functional teams.



**Education and Experience Requirement of the** Scientist - Senior **includes** :




+ 7-10 years experience in pharmaceutical industries

+ Experience with analytical method validation, product testing and/or GMP investigations

+ Degree in Chemistry or Biological sciences.



**Additional Information:**




+ Contract assignment, duration 6 months.

+ Work schedule: full-time, first shift. (9:00 AM - 5:00 PM)



**Kelly Temporary Employee Perks:**




+ Group medical, prescription, vision, dental, life, and short-term disability insurance options that are available for purchaseand the coverage is portable*

+ Service bonus plan and Holiday pay plan, if qualified

+ Weekly electronic pay options

+ Free online training campus available

+ Exclusive online employee community

+ Corporate discounts



**Apply Now!**



This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position you must submit your resume to the Scientific Recruiter listed below:



Sandy at: Sanm174@KellyServices.com



Thank you for your interest in the assignment.






**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

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Posted: 2019-10-16 Expires: 2019-11-16

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Scientist - Senior

Kelly Services
Lexington, MA 02421

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