Quality Assurance Analyst
- - QA
- Indianapolis, IN, USA
- Full Time
Quality Assurance Analyst
We are currently seeking a Quality Assurance Analystwith quality auditing experience in a regulated setting related to drug development. The Quality Analyst plays a key role in assuring the quality systems 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. The successful candidate will have some quality assurance work experience in pharma, biotech, or CRO.
AIT Bioscience (AITB), a Nexelis Company, 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 bioanalytical support for the development of new medicines, ranging from early-Discovery to Pre-Clinical support through to Clinical and Commercialization services.
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.
Fully qualified candidates may expect competitive compensation, commensurate with experience. AITB offers a generous benefits package including medical, dental, vision, life, and disability insurance, 401(k) retirement plan, and the opportunity to work with a talented, dedicated and energetic workforce.
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 3-5 years of quality experience in a related field (pharma, biotech, or CRO). Direct quality auditing experience in a regulated setting related to drug development preferred.
- B.S. in a scientific or medical field, or equivalent 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.
Our laboratory runs on a fully electronic platform. Successful candidates will enjoy and be adept at working with technology and computer-based systems. At AIT Bioscience, we value you as a person, support your personal growth and development, and want you to succeed. This opening is a first-shift position, with flexibility needed to occasionally pivot to alternate hours as directed. If you are a qualified candidate and excited about the opportunities for success and growth we offer, please apply and submit your resume and cover letter with desired salary range.