Ensure accuracy, consistency, and conformance with GLP regulations for internal documentation and processes.
Requirements
- Two years of Quality Assurance and three years of Good Laboratory Practices (GLP) audit experience required
- Solid foundation and knowledge of Good Laboratory Practices (GLP)
- Good organizational and communications skills; ability to read and understand protocols, SOPs, and technical guidelines
- A working familiarity with regulatory guidelines is preferred.
Responsibilities
- Review protocols, procedures, data, reports, and other documentation for internal accuracy, consistency, and conformance with GLP regulations.
- Files protocols, amendments, deviations, inspections and other quality documents appropriately.
- Prepares, issues, and tracks reports of observations noted during audits and inspections.
- Reviews and evaluates addressed deficiencies for clarity, completeness, correctness, and potential impact on compliance status.
- Perform phase inspections of ongoing studies.
- Perform facility audits to ensure departmental compliance with the regulations.
- Reviews equipment calibrations, qualifications, and validations for adherence to company procedures (e.g., SOPs) and federal regulations.
Other
- Bachelor's degree in biology, chemistry, or other related degree concentration
- Strong computer, scientific, and organizational skills
- Excellent communication (oral and written) and attention to detail
- Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
- Authorization to work in the United States indefinitely without restriction or sponsorship
