Duration: 12+ months
Job Description:
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.
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.
Qualifications: - 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.
- 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.
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit .
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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