AIT Bioscience
  • - QA
  • Indianapolis, IN, USA
  • Salary
  • Full Time

We are seeking talented individuals to become part of an innovative bioanalytical contract research organization (CRO) in Indianapolis, IN. AIT Bioscience seeks a talented, experienced local quality assurance analyst.

The Quality Assurance (QA) Analyst is an entry to mid-level position, working under the supervision of the Quality Assurance Director. The major focus of this position is to act as an independent auditor in a bioanalytical laboratory, reviewing regulated bioanalytical data and final reports.

Additionally, the QA Analyst will participate in:
• Review of standard operating procedures
• Execution of approved test scripts in support of software and/or template testing
• Review of data records pertaining to study specific records, training, equipment, facility, and IT records
• Review of non-study related data
• Study scheduling

The Quality Assurance Unit has been an early adopter in the use of electronic laboratory note books for regulated bioanalysis. The review and audit of data and workflows in electronic record keeping formats is ongoing and an important facet of this full time position.

Be a part of an exciting and growing CRO that is a difference maker in the industry!

Job Duties
• Conduct audits of bioanalytical method validations and production studies;
• Conduct audits of routine processes and procedures of the laboratory and facilities;
• Report audit findings to management according to standard operating procedures;
• Identify areas of improvement and efficiencies and report these to management;
• Follow established standard operating procedures;
• Maintain current understanding of requirements for conducting regulated bioanalysis;
• Maintain the confidentiality of all AIT Bioscience clients, data and intellectual property.
• Execute other duties as assigned by management with flexibility and critical thinking.

Qualifications and Required Experience
• A bachelor's degree in a scientific or medical field from an accredited institution;
• 3-5 years of related work experience in a regulated drug/device environment
• 1 – 2 years Quality Assurance audit experience preferred
• Demonstrated ability to accurately describe an audit's study observations, findings, and other documentation in a clear and succinct manner; critically assess factors that affect the integrity and quality of study data.
• Rudimentary scientific understanding of bioanalytical concepts;
• Organize and execute all assignments in an electronic environment;
• Consistently complete tasks in a timely fashion;
• Ability to multi-task and successfully complete projects to meet client and internal timelines;
• Independently audit bioanalytical method validations and production sample analysis data packages and reports;
• Independently audit in-life processes and data integrity inspections;
• Working knowledge of 21 CFR Parts 11, 58, and 320 and drug development processes;
• Strong sense of integrity and ethics.

Certificates, Licenses, Registrations
• Not debarred by United States FDA from employment in FDA-regulated industries










AIT Bioscience
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