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 (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) 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
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Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's 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.
