Bioanalytical Quality Assurance Specialist
- Expired: over a month ago. Applications are no longer accepted.
Based in Germantown, MD, the Bioanalytical Quality Assurance Specialist will be responsible for ensuring that the organization meets its business objectives through the effective implementation, management, and auditing of the quality systems.
- Comply with the Company's Health and Safety, and Radiation Safety Program.
- Quality systems - to audit assigned aspects of the Company's regulated activities, with the exception of the Finance Department, and report to Test Site Management any non-compliance to the Company SOPs, protocols, policies, or relevant regulations.
- Identify critical non-compliances and report them immediately to the Study Lead, Director of Quality Assurance, and Test Site Management.
- Provide advice and support to assigned functions with regards to quality issues.
- Schedule and execute audits of plans, data, and reports for accuracy and compliance for regulated studies.
- Audit laboratory activities performed by operations for compliance.
- Schedule and execute facility audits of equipment, systems, and processes in compliance with QAU SOPs.
- Provide, track, and close written audit reports for all auditing activities.
- Contribute to the Quality Assurance Metrics Report to Management.
- Provide support for Regulatory and client inspections.
- Quality Assurance Unit - to adhere to the operations of the QAU and to make recommendations for further implementation or improvement of any of its systems.
- To prepare standard operating procedures for use by the Company as required.
- To assist the Company, meet its business objectives by demonstrating to Sponsors the quality processes and continuous improvement activities within the Company.
- Associates / equivalency in related field + 4 years experience OR Bachelors of Science in related field + 2 years experience.
- Experience working in a CRO Quality Department performing auditing tasks.
- Bachelors of Science in Chemistry + 2 years experience working in the regulated pharmaceutical industry (preferred)
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