Job Description:
• Perform review of a variety of routine and complex analytical analysis experiments conducted on pharmaceutical and biopharmaceutical compounds
• Ensure analyses are following validated or experimental analytical procedures
• Compare results to methodology, protocol and product specifications, Standard Operating Procedures (SOPs) acceptance criteria, and Good Manufacturing Practices (GMP)
• Review data entered into databases and reports and monitor the quality of the laboratory data
• Evaluate laboratory data for compliance with analytical methods, client directives, and SOPs
• Review sample results for scientific soundness, completeness, accurate representation of the data, and final reported results
• Communicate with laboratory staff to proactively maintain the quality of laboratory documentation
• Deliver 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
• Facilitate conversations with lab staff on best documentation practices and addressing quality findings
• Identify and support process improvement initiatives
• Perform 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)
• Demonstrated experience of HPLC data review and Empower strongly preferred
• Previous experience in GMP regulated laboratory environment preferred strongly preferred
• Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP
• Thorough knowledge of chromatography
• Strong technical knowledge including an understanding of laboratory procedures, methodology, and standards
• Strong verbal and written communication skills
• Strong attention to detail
• Ability to balance time and remain focused on work to meet goals
• Ability to train staff on basic review techniques
• Ability to independently review laboratory reports and analytical methods
• Ability to deal with multiple and changing priorities
• Ability to provide clear and concise feedback and/or documentation of results
• Ability to work in a collaborative team environment
• Ability to work efficiently in a remote capacity
Benefits:
• Health and wellbeing support
• Work-life balance
• Remote work flexibility
Apply Now
Apply Now