Indiana Healthcare Jobs

Data Review Specialist

Indianapolis, IN

Direct-Hire Opportunity

Monday-Friday, 8AM-5PM

Kelly Science & Clinical has an excellent direct-hire opportunity for someone with previous analytical chromatography laboratory experience. This opportunity is with a global leader in the forensic, food, environmental, pharmaceutical, AgroSciences, clinical diagnostic, and cosmetic industries, with lots of opportunity for growth and continued learning. We are interviewing and hiring immediately!

Responsibilities

• Perform review of routine and non-routine analytical data generated using techniques such as, but not limited to, UPLC/HPLC, Dissolution, GC, Thermogravimetric DSC/TGA, and KF titration to support early phase pharmaceutical small to medium molecules with pre-set timelines

• Interact with laboratory staff to ensure all data review are appropriately and efficiently corrected and documented

• Assist with technical report writing and training of laboratory personnel

• Responsible for ensuring integrity of laboratory data & perform mathematical calculations as part of data review

• Maintain the highest level of proficiency in terms of those duties and responsibilities as required by auditors/data reviewers

• Perform independent laboratory data audit to ensure continuous GMP/GLP compliance standards in all areas of responsibility, as appropriate

• Recognize errors, identify root causes, and implement process improvements

• Assist with data integrity of analytical data for pharmaceutical small to medium molecules

  The ideal candidate would possess:

• Good understanding of analytical sciences, drug development process, GMP/GLP requirements, and pharmaceutical industry trends

• Previous experience conducting, analyzing, and reviewing data for analytical methods such HPLC, UPLC, Karl Fisher, Dissolution, and Multi-product/ multi wavelength methods

• Good knowledge of three main pharmacopoeias (Japanese; JP, US; USP and European; Ph. Eur.) and ICH guidelines related to pharmaceutical oral solid dosage & parenteral drug testing

• Previous experience in Analytical Development, Quality Control, or Quality Assurance

• Understanding of experimentation/data analysis using Empower software and familiarity with ELN (Electronic Notebook)

• Excellent communication (oral and written), attention to detail and experience interacting with people from a wide range of skill levels

• Strong client service skills, self-motivated, detail-oriented, result-driven and highly flexible team-player in a fast-paced working environment.

• Strong computer, scientific, and organizational skills.

Required Qualifications

• Bachelor's degree in analytical chemistry, biochemistry, chemistry or other related degree concentration, or equivalent directly related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)

• At least two years’ experience in laboratory chromatography analyses, Quality, Regulatory, or related experience to support pharmaceutical oral solid dosage & parenteral drug product/substance testing

• Authorization to work in the United States indefinitely without restriction or sponsorship

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 interests—it’s 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, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re 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. 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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm