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Analytical Validation Consultant

Kelly Services

Cambridge, MA
Job Code:
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Job Details

Job Title Analytical Validation Consultant

Jobid US51FPAG_BH1443346

Location: Cambridge, MA, 02238, USA

Description **Instrument Validation Consultant**

3-6 Month Contract Length with Possibility of being extended.

Cambridge MA

**Essential Functions and Responsibilities:**

+ Manage the validation life cycle for analytical instruments and their associated softwares including but not limited to HPLC, ChemiDoc, Endotoxin Reader, pH meter, osmometer, Vi-Cell cell counter, MSD plate reader and analytical balances.
+ Validation documentation creation and development including GxP and 21 CFR Part11 Assessments, Change Control, Validation Plans, Risk Assessments, Requirements/Design/Functional Specifications, Supplemental IQ/OQ/PQ Protocols, Traceability Matrices, Summary/Final Reports, and Standard Operating Procedures according to company procedural requirements.
+ Managing vendor installations and vendor validation documentation
+ Routing of documentation
+ Test execution and deviation management
+ Planning and scheduling of validation and validation life-cycle deliverables.
+ May be required to assist with Excel Spreadsheet validation
**Minimum Requirements:**

+ BS or MS in a life science, engineering or equivalent work experience
+ Minimum of 5 years working within a GxP regulated setting (Laboratory, Quality, Manufacturing, IT)
+ Familiarity with a variety of Laboratory Instrumentation/Equipment – Chemistry/Microbiology/Molecular Biology
+ Troubleshooting various vendor instrument software applications
+ Exposure to lab operations and scientific processes associated with various area (Chemistry, Microbiology, Molecular, Environmental Monitoring etc.)
+ Understanding of GxP, GAMP, CFR s/ Annex 11 as they relate to the laboratory validation
+ Understanding of applying SOPs, work instructions and regulatory requirements to the Systems Validation
+ Ability to work independently and as a group on multiple projects at once
+ Work as a liaison between IT and Laboratory Departmental Management
+ Ability to adapt and work well with others specifically Quality Assurance with review and approval of documentation
+ Candidate must be detailed oriented with strong verbal and written communication skills (e.g., technical and legible writing skills, validation documents and etc.).
+ General knowledge of basic lab safety principles
+ Understanding of the Validation Life-cycle (GAMP 5)
+ Understanding of business processes as applicable to the laboratory
+ Familiarity with Kneat software is preferable.
**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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