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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.

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Science & Clinical?

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