Senior Associate, Quality Assurance
Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology, ELUTYX™. We have built a robust product pipeline of drug delivery solutions designed to reduce the complexity and burden of the current standard of care and position ourselves as a leader in the ophthalmic space. Our culture encourages out-of-the-box thinking, cross-functional collaboration, and creativity.
About the Role
The Senior Associate, QA will collaborate with all departments to provide Quality Assurance (QA) oversight for the production of Drug Products, supporting end-to-end operations from technology transfer and clinical production through commercialization. This role ensures QA oversight of Quality Control (QC) activities to maintain compliance with applicable regulatory requirements (e.g., GMP, GLP) and internal quality standards, while ensuring QC testing, documentation, and data integrity practices meet established procedures and support product quality and safety. The individual will also provide phase-appropriate cGMP guidance throughout the product lifecycle.
Responsibilities
- Provide QA support for site operations, including in-house manufacturing and activities performed at CDMOs, as well as distribution of Ocular product through the supply chain workflow.
- Offer on-floor support during critical manufacturing processes.
- Release manufacturing suites and oversee batch/product changeovers for continuation of manufacturing activities.
- Participate in cross-functional teams to resolve Quality-related issues impacting operations.
- Review and approve documentation such as Manufacturing Batch Records (MBRs), product specifications, change controls, deviations, and CAPAs.
- Participate in Change Control Review Board and provide Quality input and assessment.
- Perform quality-related activities within Quality Systems, including Change Control, Deviation Reporting, and CAPA.
- Author, review, and approve internal quality documents (SOPs, investigations, etc.).
- Support QA leadership in maintaining the QA Operations function in a state of compliance and inspection readiness.
- Support Annual Product Review (APR) Reports and analyze data to ensure process control.
- Review and approve QC documentation, including test records, analytical data, and logbooks.
- Ensure adherence to SOPs, test methods, and regulatory requirements (FDA, EMA, ICH).
- Review and approve Certificates of Analysis (CoA), analytical test results, reports, and stability data.
- Perform other quality assurance duties as assigned.
Requirements
- Bachelor’s degree in a relevant scientific discipline.
- 5+ years of experience in the pharmaceutical, biotech, or medical device industry.
- Strong knowledge of GMP, GLP, and regulatory expectations.
- Understanding of analytical testing and laboratory workflows.
- Familiarity with OOS investigations, deviations, and CAPA processes.
- Excellent organizational skills and attention to detail.
- Strong verbal and written communication skills.
- Ability to work efficiently in a team and strong interpersonal skills.
- Computer literacy, including proficiency in MS Office, Excel, and PowerPoint.
- Ability to make decisions and resolve issues with minimal guidance.
Working Conditions
- Primarily office environment.
- Clean Room / Manufacturing Environment (when required to provide on-floor QA support).
Pay
$109,000 USD - $121,000 USD