Data Reviewer Scientist - Rochester MI Job Listing at Kelly Services in Rochester, MI (Job ID US3588819_BH9911417)

Description

Scientist, Data Reviewer –  Rochester MI

Kelly Science & Clinical has an opening for a long-term, contracted, fully-benefitted, Data Reviewer Scientist for one of our reputable clients in the Rochester MI area.

Salary range/work setup/hours: $90-95/yr and based on experience/100% onsite/M-F, 8AM – 5PMEST; some flexibility with working hours applicable

Primary Responsibilities and Experience

• Validates analytical methods for Finished Product and Raw Material release and stability testing
• Evaluates, troubleshoots/improves existing analytical methods when necessary
• Prepares method validation protocols, reports, and analytical test methods
• Performs work to support project as assigned with little oversight
• Presents analytical data to project team for review and discussion
• Reviews and approves laboratory test data and documentation (e.g., notebooks, raw data and technical documentation, test method, validation protocol, or validation report) for completeness and compliance when necessary
• Reviews and evaluates drug substance supplier's technical documents to ensure internal test requirements are adequate
• Uses laboratory software for analyses
• Is alert to and detects abnormalities during performances of tests
• Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping
• Troubleshoots instrumentation and performs subsequent analyses Investigations
• Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action
• Participates in root cause identification of complex laboratory investigations
• Writes, edits, and reviews SOPs and laboratory investigations
• Trains junior Scientists/Chemists on analytical techniques
• Continuously updates knowledge with respect to the latest technologies related to analytical science
• Maintains assigned training records current and in-compliance
• Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, and chemical theories, methodologies, and procedures Compliance
• Identifies need for SOPs and writes or revises, as appropriate
• Performs work in a timely and safe manner conforming to regulatory, company and compendial requirements within pharmaceutical manufacturing setting.
• Works in compliance with cGMP/cGLP regulations
• Documents data generated in notebooks/worksheets/LIMS in compliance with SOPs
• Takes active role in auditing laboratory logbooks/documentation to ensure compliance
• Follows internal processes related to controlled substances Safety
• Follows EH&S procedures to ensure a safe work environment
• Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS
   

Education/Background/Qualifications:

• Bachelor of Science Degree, Master's Degree, or PhD in chemistry, chemical engineering, or related field with 3-4 years' relevant analytical experience as well as quality focused / data review background
• Has strong knowledge of laboratory software and has expanded knowledge of chromatographic software (e.g., Waters Empower, Agilent ChemStation and Sotax WinSotax), using custom fields, custom calculations, and custom reports
• Proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.
• Thorough knowledge of applicable safety and standards guidelines, such as FDA, ICH, SOP, cGMP, GLP, DEA regulations and/or MSDS
• Competency in Microsoft Office Suite Skills & Abilities
• Ability to critically review and analyze data, interpret information, and draw conclusions from relevant or missing information
• Ability to display and analyze data in a logical manner
• Strong verbal and written communication skills as well as good computer skills
• Strong attention to details and accurate record keeping
• Establish and maintain cooperative working relationships with others
• Solid organizational skills
• Ability to coach less senior staff and develop laboratory skills and ability
• Ability to take initiative, set priorities and follow through on assignments
   

For more information or to be considered, please contact me directly at Tierra.Barbour@kellyscientific.com or at 804-991-0745

 

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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