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30 days old

Analytical Data Reviewer

Kelly Services
Boulder, CO 80305
**Analytical Data Reviewer/Technical Writer**


**Temp role (Could possibly turn permanent)**


**$25-$30 per hour**


A minimum of 2 years of experience in a GMP Environment is required


**SUMMARY**


Ensures the quality and accuracy of analytical test data and documents by performing the following duties:


**ESSENTIAL DUTIES AND RESPONSIBILITIES** include the following.


+ Performs full review of analytical testing data to include: raw materials, in-process samples, API-release lots, validation/transfer data and stability results generated by Research & Development (R&D) or Standards and Stability (S&S) Analytical Chemists.


+ Verifies calculations, document versions, supporting logbook data, raw data (e.g. chromatography data, integrations, calibrations, system suitability) and transcription of data into final reports.


+ Ensures compliance with GxPs, SOPs and Client requirements within clinical, registration and validation programs with clinical phase appropriate (pre-clinical to phase III) review.


+ Performs comparison of results to specifications and batch records.


+ Participates in review of standards, reagent preparation and instrument logs.


+ Assists in the development and review of clinical method SOPs and specifications.


+ Assists in the drafting and review of controlled SOPs, methods, and specifications within the Quality organization.


+ Assists in the drafting and review of transfer, verification and validation protocols and reports.


+ Assists in the drafting and review of project reports pertaining to analytical method development and qualification.


+ Authors and coordinates change control documentation in support of analytical activities required for manufacturing process start up.


+ Works closely with laboratory staff to monitor lab performance, helps investigate root causes of errors and identifies areas for improvement.


+ Copying, filing and scanning documents as required for internal and customer use.


**EDUCATION and/or EXPERIENCE**


Bachelors degree in chemistry or related sciences with minimum of 2 years of relevant experience in a GMP environment


**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 (plus, did we mention we provide a ton of benefits ?). 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-05-24 Expires: 2021-07-24

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Analytical Data Reviewer

Kelly Services
Boulder, CO 80305

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