Associate Scientist I – R&D

Job Description

Job Summary:

• The Data Review Scientist I will review testing associated with raw materials, in-process samples, finished products, and stability samples.
• The ideal candidate will have strong attention to detail, scientific judgment, and the ability to identify and resolve data or documentation discrepancies.

Duties and Responsibilities:

• Review analytical data, laboratory records, and supporting documentation generated by QC laboratories.
• Review data from techniques such as HPLC, GC, spectroscopy, dissolution testing, and wet chemistry methods.
• Verify calculations, results, specifications, instrument outputs, chromatograms, and associated documentation for accuracy and completeness.
• Ensure laboratory records comply with approved methods, specifications, SOPs, GMP requirements, and Good Documentation Practices.
• Identify errors, discrepancies, atypical results, or documentation deficiencies and work with laboratory personnel to facilitate resolution.
• Review data associated with raw materials, in-process samples, finished products, and stability studies.
• Utilize laboratory information systems and other electronic systems to review and track analytical data and sample status.
• Support investigations, deviations, OOS/OOT events, and other quality activities as assigned.
• Maintain accurate and traceable records in accordance with applicable data integrity expectations.
• Collaborate with QC analysts, laboratory leadership, Quality Assurance, and other teams to support testing and product-release timelines.
• Follow applicable safety, quality, regulatory, and site procedures.

Education & Experience:

• Bachelor’s degree in required, preferably in Chemistry, Biology, Biochemistry, or a related scientific field.
• 2+ years of relevant experience preferred, ideally in a laboratory, pharmaceutical, biotechnology, or regulated environment.
• Experience with laboratory data review or analytical laboratory testing preferred.

Knowledge, Skills, and Abilities:

• 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 is a must.
• Strong attention to detail with the ability to critically evaluate scientific data and identify discrepancies.
• Strong problem-solving, organizational, written, and verbal communication skills.
• Proficient computer skills, including Microsoft Office and laboratory information/electronic data systems.
• Ability to work independently and collaboratively in a dynamic environment.