BS/BA degree in Biology (or related field) with a minimum of 3 years of relevant experience in Quality Assurance (preferably GLP) with at least 2 years of experience auditing bioanalytical/immunoanalytical (large molecule) processes and procedures. Knowledge of GCP, CLIA and experience with Watson LIMS a plus.
Adherence to laboratory health and safety procedures.
Adherence to Standard Operating Procedures (SOPs).
Adherence to applicable company policies and guidelines.
Adherence to federal and/or local regulations, as applicable.
Perform protocol, data, interim data release, and final report audits and conduct in-life phase inspections as required for compliance with GLPs, SOPs, and Sponsor requirements.
Observe technical and professional staff for adherence to health and safety, SOP, and GLP standards.
Conduct internal facility and process audits as required for compliance with GLPs and SOPs.
Conduct subcontractor inspections and vendor audits.
Participate in validation activities for equipment and software (compliance to 21 CFR Part 11).
Report in writing all findings from audits and inspections to Test Facility/Test Site Management and Study Directors/Principal Investigators.
Assist and represent quality assurance during inspections from existing or potential clients and regulatory agencies, e.g. FDA, EPA, OECD and CLIA.
Maintain properly indexed quality assurance records, including protocols, correspondence, inspection/audit status reports, audit logs, and other QA records.
Perform duties independently and provide leadership and mentoring to auditors and operational staff
· Attends continuing education courses as appropiate.
· Maintain an active membership in a regional/national chapter of a professional quality assurance society.