Aerotek Laboratory Quality Auditor in Indianapolis, Indiana
A Contract Research Organization is looking to add a Quality Auditor to their Global Quality Assurance team!
This role will audit the lab practices, SOP, and regulations for any of the sites and lab disciplines in North America. This team will host, prepare, and and orchestrate client audits as well as final study reports. They will be auditing documentation, capturing screenshots of the electronic lab software, performance monitoring of the research data, and the quality assurance procedures that the team is adhering to based on the clients requirements.
• Manages the resources for the internal audit programme and ensures audits are conducted according to QA procedures.
• Audits include but are not limited to internal audits and effectiveness checks.
• Manage the QA procedures for the quality oversight of referral labs. Work with the Expanded Laboratory Management Solutions, ELMS, team to ensure that appropriate quality standards and procedures are followed.
• Manages sponsor audits according to QA procedures
• Reviews analytical plans, and analytical reports to ensure that appropriate procedures and regulations are followed.
• Discusses critical issues to operational departments to ensure appropriate resolution.
• Revises QA procedures when requested.
• Manages the delivery and retrieval of QA documentation during sponsor or regulatory audits/inspections.
• Trains junior members of the QA team.
Additional Skills & Qualifications:
BS degree in science field
Need at least a year of hands on lab testing on human biological samples. Could be from healthcare, research, clinical, hospital, diagnostic labs, reference labs, etc.
Need at least a year of auditing experience from a lab or scientific setting
Need to have experience with at least one of the following: leading projects, management/lead roles, negotiating with clients, trackwise software, GLP/GCP, clinical trials
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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