QA Auditor - GLP

The QA Auditor and Senior QA Auditor roles are responsible for leading and performing quality assurance (QA) audits, inspections and monitoring procedures to ensure compliance for contracted bioanalytical services supporting clinical trials and GLP-regulated studies. This role provides consultation and facilitates communication between functions and departments to ensure quality standards are met.

Essential Position Responsibilities:

• Observes technical and professional staff for adherence to GLP and GCP requirements, GCLP standards, SOPs and related guidances.
• Performs analytical plan, data, and report (interim, draft, final) audits and conducts in-process phase inspections as required for compliance with GLPs, GCPs, GCLPs, SOPs, and other applicable quality standards.
• Conducts internal facility and processes audits as required for compliance with regulatory requirements and SOPs.
• Performs assessments of service providers.
• Assists and represents quality assurance during inspections from existing or potential clients and regulatory agencies, e.g. FDA, CLIA, etc.
• Ensures coordinated and timely audit responses.
• Audits validation activities for analytical methods, equipment and software.
• Reports in writing all findings from the audits and inspections to Test Site Management and Project Manager/Principal Investigator (and Study Director/Testing Facility Management for GLP studies).
• Maintains properly indexed quality assurance records, including the Master Schedule, protocols, analytical plans, correspondence, inspection/audit reports, audit logs, and other QA records.
• Performs regulatory reviews of validation and qualification SOPs.
• Develops and delivers relevant training content and ensures all operational staff receive appropriate quality and regulatory training.
• Monitors compliance to identify trends.
• Performs duties that support the Quality team’s initiatives.
• Performs assigned responsibilities independently.
• May provide guidance and assist junior auditors and operational staff.
• Job Requirements

• S. / B.A. degree in Biology (or related field) with at least 2 years of experience auditing in a regulated environment performing bioanalytical immunoanalytical (large molecule) processes and procedures; or a minimum of 5 years or more of relevant experience auditing in a regulated environment performing bioanalytical immunoanalytical (large molecule) processes and procedures.
• Must be able to interpret scientific data and regulatory standards.
• Must have GLP proficiency.
• Prior CRO experience, Watson LIMS experience, and a general knowledge of GCP, GCLP, CLIA a plus.
• Must have excellent written and verbal communication skills.
• Able to work independently and manage priorities, as well as operate a team member.
• Must be able to set realistic expectations with operational staff.
• Must be solution oriented and able to present information in an objective manner that supports compliance and operational success.
• Must be able to comfortably and successfully operate in a dynamic environment with shifting priorities.
• Must be able to collaborate and partner at all levels of the organization to accomplish deliverables and meet quality standards.
• SEND RESUME ASAP!

Job Type: Full-time

Pay: $80,000.00 - $110,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off

Schedule:

• 8 hour shift

Experience:

• GLP: 3 years (Preferred)
• Auditing: 5 years (Preferred)

Work Location: One location

Salary : $80,000 - $110,000