Qa Auditor Jobs

Smithers PDS LLC (Pharmaceutical Development Services) offers a comprehensive range of pre-clinical and clinical services for all phases of drug development. Our expert scientists perform large molecule bioanalysis, assay development, validation, and sample analysis at our GLP- and GCP-compliant laboratories. Smithers PDS is seeking a QA Auditor to join our team in Ewing, NJ. The QA Auditor role is 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.

Corporate Responsibilities:

• Adherence to federal and/or local regulations as applicable.
• Adherence to applicable company policies and guidelines.
• Adherence to Standard Operating Procedures (SOPs).
• Adherence to laboratory health and safety.

Essential Position Responsibilities:

• Ensures coordinated and timely audit responses.
• Performs assigned responsibilities independently.
• Maintains properly indexed quality assurance records, including the Master Schedule, protocols, analytical plans, correspondence, inspection/audit reports, audit logs, and other QA records.
• May provide guidance and assist junior auditors and operational staff.
• Observes technical and professional staff for adherence to GLP and GCP requirements, GCLP standards, SOPs and related guidance.
• 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).
• Assists and represents quality assurance during inspections from existing or potential clients and regulatory agencies, e.g. FDA, CLIA, etc.
• Assists or perform other job duties as assigned.
• Performs duties that support the Quality team’s initiatives.
• Performs assessments of service providers.
• Audits validation activities for analytical methods, equipment and software.
• Conducts internal facility and processes audits as required for compliance with regulatory requirements and SOPs.
• Performs regulatory reviews of validation and qualification SOPs.
• 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.
• Monitors compliance to identify trends.
• Develops and delivers relevant training content and ensures all operational staff receive appropriate quality and regulatory training.

Job Requirements

• BS / BA 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.
• Prior CRO experience, Watson LIMS experience, and a general knowledge of GCP, GCLP, CLIA a plus.
• Must have GLP proficiency.
• Must be able to set realistic expectations with operational staff.
• Must have excellent written and verbal communication skills.
• Must be able to collaborate and partner at all levels of the organization to accomplish deliverables and meet quality standards.
• Must be solution oriented and able to present information in an objective manner that supports compliance and operational success.
• Able to work independently and manage priorities, as well as operate a team member.
• Must be able to operate comfortably and successfully in a dynamic environment with shifting priorities.
• Must be able to interpret scientific data and regulatory standards.

Professional Responsibilities: (if applicable)

• Maintain an active membership in a regional/national chapter of a professional quality assurance society
• Attends continuing education courses, as appropriate.

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