Quality Assurance Specialist
Ora
Summary
The Quality Assurance Specialist is a full-time NIGHT SHIFT, on-site position based in Ronkonkoma, NY. This role is responsible for supporting and maintaining quality systems, including reviewing and approving batch records, change controls, deviations, CAPAs, and other GMP documentation.
Job description
Role Description
The Quality Assurance Specialist is a full-time NIGHT SHIFT, on-site position based in Ronkonkoma, NY. This role is responsible for supporting and maintaining quality systems, including reviewing and approving batch records, change controls, deviations, CAPAs, and other GMP documentation.
- Perform and assist with internal and external audits
- Monitor compliance with SOPs and regulatory requirements
- Collaborate with production, packaging, and R&D teams to ensure consistent product quality
- Conduct routine inspections
- Participate in root-cause investigations
- Recommend improvements to quality processes and procedures
- Support training initiatives, documentation updates, and continuous improvement activities
Requirements
- Strong skills in Quality Assurance and Quality Control for OTC or pharmaceutical manufacturing environments
- Skills in Quality Management and Quality Auditing, including internal audits and supporting external regulatory or client audits
- Demonstrated knowledge of Good Manufacturing Practice (GMP) and familiarity with relevant FDA and industry guidelines
- Excellent attention to detail, strong documentation and organizational skills, and proficiency with quality-related software or electronic systems
- Effective communication and collaboration skills to work cross-functionally with operations, technical, and leadership teams
- Bachelor's degree in a scientific or engineering discipline (such as Chemistry, Pharmacy, Biology, or Chemical Engineering) or equivalent experience in quality roles
- Experience in OTC, pharmaceutical, or CDMO operations, and exposure to solid dose manufacturing, is highly beneficial
- Ability to work on-site in Ronkonkoma, NY, manage multiple priorities, and contribute to a fast-paced, growth-oriented environment
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.