BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a QA Compliance Auditor to work for a leading San Diego biotechnology company.
QA Compliance Auditor
Responsible for activities involving Quality Systems to ensure compliance with applicable regulatory requirements and company SOPs. The Compliance Auditor is responsible for conducting routine audits of GMP operations, writing audit reports and evaluating corrective actions resulting from audits. This position will assist with planning, coordinating and documenting activities related to the following Quality Assurance Systems: batch production record review, material lot release, GMP training program, internal audit program, the stability program and tracking and trending of deviations, investigations, corrective actions and supplier qualification. The position will be interacting with cross-functional groups such as Materials Management, Analytical Development, Chemical Research and Development, Pharmaceutical Sciences (Formulations) and Regulatory.
Essential Duties and Responsibilities:
Performs internal GMP audits of pharmaceutical development activities and quality operations;
Performs external GMP compliance audits of Contract Research, Manufacturing or Laboratory Organization sites;
Prepares written reports of observations and recommendations. Ensures appropriate responses to the observations are received, closed and completed. Follow-up to ensure observations are closed out. Assist in developing implementation strategies and assesses effectiveness of corrective actions;
Assesses and approves audit corrective action plans for internal and external GMP Compliance audits;
Leads or participates in meetings post internal audits to discuss and drive to closure unresolved issues with auditees, stakeholders and/or Senior Management;
Develops, maintains and reports critical metrics on the audit response process. Informs Senior Management of adverse trends;
Assists in hosting regulatory facility inspections by acting as scribe and/or reviewing documents and identifying and calling operational staff to answer questions as needed;
Participates in response to regulatory inspection observations. Authors responses if assigned. Leads response writing effort if assigned;
Identifies gaps in corporate practices, policies and procedures and helps prioritize work based on current regulatory environment, guides and regulations;
Serves as a Quality representative on cross-functional teams;
Develops and implements systems to ensure inspection readiness;
Assisting in training of Quality Assurance staff to support internal audits;
Performs any other tasks as requested by Management to support Compliance oversight activities.
Education: Bachelorâ€™s Degree in area of specialty; BA/BS in Biology or related Science preferred
Experience: 8+ years of increasing responsibility and preferably applicable Quality experience in a pharmaceutical/biotechnology environment. Knowledge of lab operations and regulatory requirements are required.
BioPhase Solutions - 22 months ago