Data Reviewer – Small Molecule
Posted 1hrs ago
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Job Description
Data Reviewer performing complex analytical analysis on pharmaceutical and biopharmaceutical compounds. Ensuring compliance with SOPs and GMP in a fully remote capacity supporting a GMP Laboratory.
Responsibilities:
- Performs review of a variety of routine and complex analytical analysis experiments that are conducted on pharmaceutical and biopharmaceutical compounds with various formulations and/or biological matrices.
- Ensures analyses are following validated or experimental analytical procedures, and compare results to methodology, protocol and product specifications, Standard Operating Procedures (SOPs) acceptance criteria, and Good Manufacturing Practices (GMP).
- Reviews data entered into databases and reports and monitors the quality of the laboratory data.
- Evaluates laboratory data for compliance with analytical methods, client directives, and SOPs.
- Reviews sample results for scientific soundness, completeness, accurate representation of the data, and final reported results.
- Communicates with laboratory staff to proactively maintain the quality of laboratory documentation.
- Delivers review findings noting deficiencies within the analytical data or reports in a clear and concise manner.
- Escalate significant deficiencies to the project leader or supervisor for assessment.
- Facilitates conversations with lab staff on best documentation practices and addressing quality findings.
- Identifies and supports process improvement initiatives.
- Performs other duties as assigned.
Requirements:
- Bachelor’s degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’) or equivalent combination of education, training, and experience.
- Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP
- Thorough knowledge of chromatography may be required
- Strong technical knowledge including an understanding of laboratory procedures, methodology, and standards
- Ability to train staff on basic review techniques.
- Ability to work efficiently in a remote capacity
Benefits:
- We support and encourage individuals to create a healthy and balanced environment where they can thrive.
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