Required Skills & Experience
BS degree with less than 1 year experience, OR Associate/certificate/high school background with 1+ year laboratory experience
Academic lab experience counts, particularly for entry-level candidates.
Looking for basic, trainable laboratory skills:
o GDP / good documentation practices o Lab safety o pH meters o Analytical balances o Pipettes/glassware o General chemistry laboratory experience
Experience with analytical laboratory testing and/or laboratory data review preferred.
Working knowledge of analytical techniques such as HPLC, GC, spectroscopy, dissolution testing, and wet chemistry.
Knowledge of GMP regulations, Good Documentation Practices, pharmaceutical quality standards, and data integrity principles required.
Nice to Have Skills & Experience
Laboratory experience with HPLC, GC, or dissolution testing is a plus
Job Description
The Assistant Scientist supports R&D and Quality Control operations through the review of analytical data, laboratory records, and supporting documentation. This role ensures testing data is accurate, complete, traceable, and compliant with approved methods, specifications, SOPs, GMP requirements, and Good Documentation Practices.
Key Responsibilities
Review analytical data, laboratory records, and supporting documentation generated by QC laboratories.
Review results from analytical techniques including HPLC, GC, spectroscopy, dissolution testing, and wet chemistry.
Verify calculations, specifications, instrument outputs, chromatograms, and test results for accuracy and completeness.
Ensure laboratory documentation complies with approved methods, SOPs, GMP requirements, Good Documentation Practices, and data integrity standards.
Identify errors, discrepancies, atypical results, and documentation deficiencies and partner with laboratory personnel to resolve issues.
Review data associated with raw materials, in-process samples, finished products, and stability studies.
Utilize laboratory information and electronic data systems to review analytical data and track sample status.
Support investigations, deviations, OOS/OOT events, and other quality-related activities as needed.
Maintain accurate, complete, and traceable records.
Collaborate with QC analysts, laboratory leadership, Quality Assurance, and cross-functional teams to support testing and product-release timelines.
Follow all applicable safety, quality, regulatory, and site procedures.