Operations On-site QA Specialist
Ora
Summary
Under minimal supervision from senior team members, this position executes written procedures associated with on-site Quality Assurance responsibilities focusing on on-site inspection of manufacturing and testing operations. The individual will have prior experience in a cGMP QA setting. With guidance from management this role will be responsible for learning the process and steps required to perform all functions independently.
Job description
Job Summary
Under minimal supervision from senior team members, this position executes written procedures associated with on-site Quality Assurance responsibilities focusing on on-site inspection of manufacturing and testing operations. The individual will have prior experience in a cGMP QA setting. With guidance from management this role will be responsible for learning the process and steps required to perform all functions independently.
Shift
Openings are available on 1st and 3rd shift.
Responsibilities Include
- Conducts on the floor reviews of all manufacturing and testing operations.
- Performs verifications required to support manufacturing and testing documentation (including but not limited to batch records, cleaning records, logbooks, and test methods).
- Assists all departments in the identification and evaluation of facility events.
- Performs on the floor reviews of executed batch records.
- Assists in the organization and/or the establishment/maintenance of relevant procedures/documents.
- Assists in audits where necessary.
- Supports the document control team in issuing records as needed.
Job Requirements And Qualifications
This position is open to candidates with a range of relevant experience levels. Candidates meeting the minimum qualifications are encouraged to apply. Final job level and compensation will be determined based on the selected candidate's education, experience, skills, and overall qualifications.
Required
Bachelor's Degree or above in a Scientific discipline or 2+ years QA experience in a regulated industry.
Preferred
Bachelor's Degree or above in a Scientific discipline with 5+ years QA experience in a regulated industry.
You Should Be Proficient In
- Good Manufacturing Practices (GMP)
- batch records
- cleaning records
- logbooks
- QA
- Quality Assurance
- test methods
Machines & Technologies You'll Use
- eQMS
- Master Control
- Document Control
Requirements
- Bachelor's Degree or above in a Scientific discipline OR 2+ years QA experience in a regulated industry
- Prior experience in a cGMP QA setting
- Good Manufacturing Practices (GMP)
- Batch records
- Cleaning records
- Logbooks
- Quality Assurance
- Test methods
- eQMS
- MasterControl
- Document Control
Benefits
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Life and AD&D Insurance
- Short-Term Disability Insurance
- Long-Term Disability Insurance
- Health Savings Account
- Flexible Spending Account
- Employee Assistance Program
- Vacation
- Paid Holidays
- 401(k)
- Advancement Opportunities
- Team-Oriented Environment
- Community Involvement
- Company Events
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.