Job Title: QC Chemistry Data Reviewer

Job Description

As a QC Chemistry Data Reviewer, you will perform reviews and investigations related to QC chemistry analysis of active pharmaceutical ingredients, in-process materials, finished products, and stability materials according to established methods. This role involves ensuring data accuracy, performing investigations, and maintaining laboratory safety and practices.

ResponsibilitiesReview test data, calculations, and results for accuracy and completeness.Perform OOS (Out of Specification), Deviation, and CAPA (Corrective and Preventive Action) investigations.Follow all procedures related to data documentation, laboratory safety, and good laboratory practices.Prepare, review, or update Standard Operating Procedures as assigned.Interpret USP (United States Pharmacopeia) or other compendia methods.Engage in additional projects as assigned.Essential SkillsBachelor’s degree in Chemistry, Biochemistry, or a related discipline.At least 5 years of experience working in pharmaceutical laboratory analysis.Experience with HPLC (High-Performance Liquid Chromatography) and GC (Gas Chromatography), preferably with OpenLab software.Familiarity with USP and FDA pharmaceutical and medical device requirements.Experience with OOS investigations, CAPA, and Deviations.Good analytical skills with knowledge of USP monographs, HPLC, and GC.Experience with Kaizen system and CAPA events documentation.Ability to justify tests and explain out-of-specification results.Additional Skills & QualificationsExperience applying knowledge of analytical equipment and testing (HPLC, GC auto-titrator, FTIR (Fourier-transform infrared spectroscopy), and compendia testing).Mid-level Chemist in career is ideal.Work Environment

You will be part of the QC Chemistry team, reporting to members of the lab team who lead the team of investigators and reviewers. You will interact with and work on tests from a hands-on lab team consisting of chemists and lab technicians. The team comprises 20 members working in a brand new 72,000 square foot lab. The lab is expanding significantly, bringing in method development, leachables, and extractables in-house in the near future, with tons of new products and significant growth since 2022. The company offers some of the best healthcare benefits and industry perks when permanent

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.