Quality Assurance Engineer I

About SpyGlass Pharma:

At SpyGlass Pharma, we are focused on improving and preserving the vision of patients suffering from chronic eye conditions, while minimizing the impact on their daily lives. We aim to achieve this by developing cutting-edge long-term drug delivery products to address common causes of blindness and getting these products to the patients that need them.

We have built a team of driven professionals with diverse expertise in ophthalmic products and drug delivery. Our accomplished scientists and engineers work alongside a seasoned leadership team with extensive experience in ophthalmology and a history of commercial success. Our unifying mantra, We create for patients doesnt just live on our walls but drives our decision making as we build the company, creating the products, processes and culture that make it happen.

This team has delivered a solid foundation of development and clinical data, enabling over $120 million in funding to date with several top-tier venture partners. We are building confidence in the performance of our lead product going into Phase 3 clinical trials.

Summary:

We are looking for a Quality Assurance Engineer I to join our team at SpyGlass Pharma. This role will be responsible for supporting the R&D and Operations teams with pharmaceutical drug development, Design Controls, and device and drug product manufacturing activities. The QA Engineer I will contribute to quality assurance oversight and ensure compliance with regulatory and industry standards, supporting SpyGlass Pharmas mission to deliver high-quality, innovative ophthalmic solutions.

Essential Duties & Responsibilities:

• Support the execution of the Quality Management System to meet regulatory requirements.
• Assist with cross-functional continuous improvement projects within the Quality Management System.
• Facilitate and assess change controls in collaboration with R&D and Operations.
• Serve as a Quality Event owner for manufacturing deviations, product investigations, temperature excursions, complaints, and CAPAs.
• Support the review and collaboration of specifications and drawings.
• Review Intraocular Lens (IOL) Device Master Records and Drug Pad Batch Records.
• Assist with the Drug Pad batch disposition process in collaboration with the Contract Manufacturing Organization (CMO).
• Provide quality support to functional teams and CMO.
• Support management in the review of design control/risk management documents, development and manufacturing protocols, reports, and batch records.
• Oversee the equipment calibration, preventive maintenance (PM), and qualification process.
• Assist in the development of Good Manufacturing Practice (GMP) documentation, including SOPs, templates, and forms.
• Perform other duties as assigned.
  

Qualifications Required For Position:

• 2 years of experience in Quality Assurance within the pharmaceutical or related industry.
• Bachelors degree in Engineering, Chemistry, Biology, or a related science.
• Experience with medical devices (intraocular lenses) is a plus.
• Working experience in pharmaceutical change control and deviation investigations.
• Strong understanding of Change Control and Quality Investigations.
• Experience in executing a Quality Management System.
• Strong attention to detail and ability to collaborate effectively in a cross-functional environment.
• Excellent written and verbal communication skills.

Why SpyGlass Pharma?

• We are offering a range of $90,000 - $110,000, based on experience and qualifications, along with an Annual Bonus opportunity.
• Share in our success with stock options, giving you a stake in the companys future.
• Comprehensive health, dental, and vision insurance plans to keep you and your family healthy and happy, with a variety of plan and coverage options.
• Generous paid time off, including holidays, vacation days, and personal leave.

SpyGlass Pharma is an Equal Opportunity Employer and participates in E-Verify. SpyGlass Pharma takes pride in 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.

SpyGlass Pharma is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to JOBS@SPYGLASSPHARMA.COM and let us know the nature of your request and your contact information.