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Quality Assurance Specialist
2 months ago
About SpyGlass Pharma
SpyGlass Pharma is a leading pharmaceutical company dedicated to developing innovative solutions for glaucoma and cataract surgery/intraocular lens replacement. Our mission is to improve patients' quality of life through cutting-edge technology and expertise.
Our team comprises professionals with diverse expertise in ophthalmic devices and drug delivery. Our accomplished scientists and engineers work alongside a seasoned leadership team with extensive experience in ophthalmology, IOL development, and commercial success.
Job Summary
The Quality Assurance Manager plays a pivotal role in ensuring the successful execution of the Quality Management System at SpyGlass Pharma. This role involves support for the Research & Development and Operations teams, ensuring that all processes meet regulatory requirements and company standards.
Key Responsibilities
- Support Quality Management System Execution: Ensure that all processes meet regulatory requirements and company standards.
- Support R&D and Operations Teams: Provide support in areas of Design Control, Product Change Management, and Risk Management.
- Raw Material Qualification and Product Release Support: Ensure that raw materials meet quality standards and products are released for distribution.
- Change Control and Quality Events Review: Review and approve change control and quality events.
- Supplier Management: Back up quality representative for suppliers, CMOs, and other external partners.
- Management Review Process: Support the management review process through data preparation and meeting minutes.
- Continuous Improvement: Lead continuous improvement projects for Quality Management.
Qualifications
- Experience: 3+ years of experience with direct quality assurance experience in the pharmaceutical and medical device industry.
- Education: B.S. in Chemistry, Biology, Engineering, or related science.
- Skills: Strong attention to detail and collaboration.
Certifications
- ASQ Certification: CQE or CQA certification preferred.
SpyGlass Pharma is an Equal Opportunity Employer and participates in E-Verify. We are committed to maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion, or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status.
