Key areas of responsibility
• Reviews complex projects and must be able to evaluate compliance with special client criteria.
• Audits laboratory data for compliance with methods and standard operating procedures and report findings.
• Audits sample result tables and analytical reports for completeness and accurate representation of the data and report findings.
• Conducts project specific inspections of laboratory procedures to evaluate compliance with analytical methods and standard operating procedures and report findings.
• Client and inspector interaction.
• Conducts general facility inspections as assigned.
• Conducts audits of vendors and subcontractors as assigned.
• Evaluates audit and inspection findings and consults with CSO regarding appropriate course of action and reporting requirements.
• Identifies issues which may require follow-up inspection and consult with CSO for scheduling follow-up inspection.
• Provides training for new staff.
• Major in biology, pharmacy, medicine or other related specialty.
• Knowledge of routine analytical methodologies.
• Thorough knowledge of GLP regulations.
• Good English (verbal and written) skills.
• Good verbal and written communication skills.
• Detail oriented and able to deal with multiple and changing priorities.
• Ability to work under minimal supervision. Interactions with supervisor are primarily to inform the supervisor of activities.
• Demonstrate proficiency with regulation and guideline interpretation, audit procedures, proper documentation and QA departmental policies and procedures.