Quality Assurance Specialist
- - QA
- Indianapolis, IN, USA
- Full Time
AIT Bioscience (AITB) is a leading bioanalytical services contract research organization (CRO), serving the pharmaceutical, biotech, and animal health industries. LC-MS/MS and multiple large molecule platforms combine to provide regulatory compliant bioassay support of the development of new medicines from Discovery to Pre-Clinical and Clinical through Commercialization.
AITB is the first and only CRO to provide solutions for all molecule types (large, small, and peptides/biomarkers) in a purpose-built facility utilizing a fully electronic analytical lab notebook system. With our customized, real-time QC system, quality has literally been built into everything we do and everywhere we do it. Bioanalytical capabilities and expertise support both stand-alone projects and full IND/NDA enabling programs, allowing AITB to support its clients with a hands-on approach, scientific collaboration, high quality, and on-time delivery.
To support our continued growth, AITB is seeking an experienced quality assurance professional to fill the role of Quality Specialist. The Quality Specialist plays a key role in assuring the quality systems of AITB remain compliant and that quality oversight of data and reports is of the highest standards. This position requires a high degree of skill, knowledge, and professionalism to both existing and future clients.
Summary of Job Responsibilities:
• Independently audit data and reports generated for regulated studies.
• Conduct in-study and facility-based inspections.
• Provide training and guidance regarding quality and regulatory compliance matters.
• Conduct vendor assessments for vendors supplying services or products for use in regulated studies.
• Conduct quality review of Standard Operating Procedures.
• Conduct quality review of equipment/instrument qualifications/validation records.
• Promote strong relationships with AITB sponsors; host quality-led sponsor audits.
• Assist in hosting regulatory agency visits.
• Maintain in-depth knowledge of regulations and regulatory guidance surrounding the conduct of regulated bioanalytical assays and drug development.
• Review and author quality-related standard operating procedures and policies.
• Facilitate the vision and tone of regulatory expectations.
Skills and Experience:
- At least 4-5 years direct quality auditing experience in a regulated setting related to drug development.
- B.S. in a scientific discipline or 5-10 years of scientific industry experience.
- In-depth knowledge and understanding of national and international regulations and regulatory guidance (21 CFR Part 58, OECD GLPs, 21 CFR Part 11, U.S FDA Bioanalytical Method Validation Guidance, EMA Bioanalytical Method Validation Guidance).
- Thorough understanding of the bioanalytical method validation process.
- Ability to independently audit regulated bioanalytical data and reports.
- Ability to learn quickly and retain/apply learnings.
- Excellent attention to detail.
- Experience hosting and/or participating in sponsor or regulatory visits.
- Ability to work in a team; mentor and train junior level auditors.
- Knowledge of and ability to effectively use automated systems; understanding of qualification/validation of equipment and software.
- Knowledge of preclinical and clinical drug development; preclinical and clinical study designs and procedures, as well as, current FDA requirements and guidance on bioanalytical method development and sample analysis.
- Excellent time management skills and the ability to multi-task.
- Registered Quality Assurance credential (RQAP-GLP or RQAP-GCP) a plus.
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