Quality Assurance Auditor I
Ora
Summary
Perform audits of basic records and reports and inspections of routine processes to assure compliance with applicable GLP regulatory requirements.
Job description
Essential Duties and Responsibilities
- Assure Charles River's compliance with applicable GLP. Communicate all identified compliance and quality risks to supervisor.
- Perform data audits to assess that records are attributable, legible, contemporaneous, original, accurate, and in compliance with regulations, SOPs, and protocols.
- Review SOPs, protocols, reports, and other quality and regulated records for accuracy, completeness, and compliance with all applicable GLP regulations.
- Maintain written and signed records of all audits and inspections as required and sign records documenting the performance of audits and inspections and reporting to management.
- Identify deviations from GLP regulations, protocols and SOPs.
- Independently perform inspections to monitor processes, facilities, equipment, personnel, materials, methods, practices, records, and controls to assure compliance with GLP regulations.
- Assist in scheduling and tracking QA audits, inspections and procedures as requested.
- Perform all other related duties as assigned.
Qualifications
Education: Bachelor's degree (B.A./B.S.) or equivalent, preferably in a life science or related discipline.
Experience: 1-2 years experience in QA role. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
Certification/Licensure: None.
Other: Knowledge of Microsoft Office applications (e.g. Word, Access, Excel). Must be able to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements. Must be detail oriented and able to effectively communicate findings verbally and in writing.
Requirements
- Bachelor's degree (B.A./B.S.) or equivalent, preferably in a life science or related discipline
- 1-2 years experience in QA role
- Knowledge of Microsoft Office applications (e.g. Word, Access, Excel)
- Must be able to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements
- Must be detail oriented and able to effectively communicate findings verbally and in writing
Benefits
- Performance Bonus
- 401(k)
- Paid Time Off
- Stock Purchase Program
- Health and Wellness Coverage
- Employee and Family Wellbeing Support Programs
- Work-Life Balance Flexibility
Company overview
Ora is the world's leading full-service ophthalmic drug and device development firm, operating as a specialized contract research organization (CRO) focused exclusively on ophthalmology. Founded in 1974 and headquartered in Andover, Massachusetts, the company has over 45 years of experience in advancing eye care innovations globally. Ora provides comprehensive research and development services spanning preclinical studies, clinical trials, regulatory strategy, and product development for both pharmaceutical and medical device companies. With operations across the United States, United Kingdom, Australia, and Asia, the company has helped clients achieve more than 85 product approvals to date. Ora's expertise covers a wide range of ophthalmic conditions including allergy, dry eye, retina diseases, glaucoma, and anti-infective therapies. The company employs over 500 ophthalmology specialists who utilize proprietary clinical models, integrated data solutions, and global regulatory strategies to accelerate product development from concept to market. Ora serves a diverse client base ranging from startups to global pharmaceutical and device companies, positioning itself as the trusted partner for ophthalmic innovation worldwide.