Quality Assurance Engineer I
Quality Assurance Engineer I
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$ 90 - 110
1 Vacancy
Job Description
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 cuttingedge longterm 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 toptier 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 highquality innovative ophthalmic solutions.
Essential Duties & Responsibilities:
- Support the of the Quality Management System to meet regulatory requirements.
- Assist with crossfunctional 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 crossfunctional environment.
- Excellent written and verbal communication skills.
Why SpyGlass Pharma
- We are offering a range of $90000 $110000 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 EVerify. 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 and let us know the nature of your request and your contact information.
Employment Type
Full-Time
