Associate Scientist I - R&D (Data Review Scientist I

• Review analytical data, laboratory records, and supporting documentation generated by Quality Control laboratories for accuracy, completeness, and compliance.
• Review data from analytical techniques such as HPLC, GC, spectroscopy, dissolution testing, and wet chemistry methods.
• Verify calculations, test results, specifications, instrument outputs, chromatograms, and associated documentation to ensure they meet established requirements.
• Ensure laboratory records comply with approved methods, specifications, standard operating procedures (SOPs), Good Manufacturing Practice (GMP) requirements, and Good Documentation Practices.
• Identify errors, discrepancies, atypical results, or documentation deficiencies and work closely with laboratory personnel to facilitate timely resolution.
• Review data associated with raw materials, in-process samples, finished products, and stability studies to support product quality and release decisions.
• Utilize laboratory information systems and other electronic systems to review, track, and manage analytical data and sample status.
• Support investigations, deviations, out-of-specification (OOS), out-of-trend (OOT) events, and other quality-related activities as assigned.
• Maintain accurate, complete, and traceable records in accordance with applicable data integrity expectations and regulatory standards.
• Collaborate with QC analysts, laboratory leadership, Quality Assurance, and cross-functional teams to support testing schedules and product-release timelines.
• Follow all applicable safety, quality, regulatory, and site procedures while performing daily activities.

Chemistry Visionary Operations Leadership Innovation Biochemistry Spectroscopy Investigation Biotechnology Collaboration Wet Chemistry Data Integrity Pharmaceuticals Detail Oriented Problem Solving Quality Control Microsoft Office Computer Literacy Quality Assurance Electronic Systems Quality Management Laboratory Testing Analytical Testing Analytical Techniques Engineering Design Process Verbal Communication Skills Standard Operating Procedure Good Manufacturing Practices Good Documentation Practices, * Bachelor’s degree required, preferably in Chemistry, Biology, Biochemistry, or a related scientific field.

• 2+ years of relevant experience preferred, ideally in a laboratory, pharmaceutical, biotechnology, or other 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.
• Strong attention to detail with the ability to critically evaluate scientific data and identify discrepancies.
• Strong problem-solving and organizational skills.
• Effective written and verbal communication skills.
• Proficient computer skills, including Microsoft Office and laboratory information or electronic data systems.
• Ability to work independently and collaboratively in a dynamic environment., * Background in Chemistry, Biology, Biochemistry, or a related discipline.
• Previous experience in pharmaceutical, biotechnology, or other highly regulated industries.
• Hands-on familiarity with laboratory information management systems and electronic data review tools.
• Demonstrated ability to collaborate with cross-functional teams such as QC, QA, and laboratory leadership.
• Comfort working in an environment that requires adherence to strict quality, regulatory, and documentation standards., Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors., Biology Chemistry Visionary Operations Leadership Innovation Biochemistry Spectroscopy Investigation Biotechnology Collaboration Wet Chemistry Data Integrity Pharmaceuticals Detail Oriented Problem Solving Quality Control Microsoft Office Computer Literacy Quality Assurance Electronic Systems Quality Management Laboratory Testing Analytical Testing Analytical Techniques Engineering Design Process Verbal Communication Skills Standard Operating Procedure Good Manufacturing Practices Good Documentation Practices High-Performance Liquid Chromatography Laboratory Information Management Systems +0

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