What are the responsibilities and job description for the PDS Quality Assurance Associate Auditor position at Smithers?
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 regulated laboratories.
Smithers PDS is seeking a Quality Assurance Associate Auditor to join our team in Gaithersburg, MD. The Quality Assurance Associate Auditor role is responsible for 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.
Salary for range for this position is $54,806 - $82,209 per year. Salary and job title will be commensurate with experience and qualifications. Smithers PDS offers a comprehensive health insurance package including a choice of 3 medical plans, dental insurance, vision insurance, 401K retirement plan and PTO.
Essential Position Responsibilities :
- This Quality Assurance Associate Auditor will be trained to perform the following :
- Observe technical and professional staff for adherence to GLP and GCP requirements, GCLP standards, SOPs and related guidance.
- Perform analytical plan, data, and report (interim, draft, final) audits and conduct in-process phase inspections as required for compliance with GLPs, GCPs, GCLPs, SOPs, and other applicable quality standards.
- Assist with the conduct of internal facility audits as required for compliance with regulatory requirements and SOPs.
- Assist and represents quality assurance during inspections from existing or potential clients and regulatory agencies, e.g. FDA, CLIA, etc.
- Support inspections from existing or potential clients and regulatory agencies, e.g. FDA, CLIA, etc.
- Ensure coordinated and timely audit responses.
- Audit validation activities for analytical methods, equipment and software.
- Report in writing all findings from the audits and inspections to Test Site Management and Principal Investigator (and Study Director / Testing Facility Management for GLP studies).
- Maintain properly indexed quality assurance records, including the Master Schedule, protocols, analytical plans, correspondence, inspection / audit reports, audit logs, and other QA records.
- Perform duties that support the Quality team’s initiatives.
- Assist or perform other job duties as assigned.
Corporate Responsibilities :
Job Requirements
Professional Responsibilities : (if applicable)
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Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
Salary : $54,806 - $82,209
