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Senior Associate, Quality Assurance

Bedford, MA

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™. Ocular Therapeutix has built a robust product pipeline of drug delivery solutions developed to reduce the complexity and burden of the current standard of care and position itself to become a leader in the ophthalmic space.

Outside of the ophthalmic realm and behind the doors of our headquarters in Bedford, MA, we strive to build a strong culture where employees can flourish and achieve their career goals. We encourage out of the box thinking, cross-functional collaboration, and creativity.

Position Summary:

The Senior Associate, QA will work in collaboration with all departments within Ocular, to provide the necessary Quality Assurance (QA) oversight for the production of Drug Products including support of end-to-end operations from technology transfer and clinical production all the way through commercialization. Additionally, they will be responsible for providing QA oversight of Quality Control (QC) activities to ensure compliance with applicable regulatory requirements (e.g., GMP, GLP) and internal quality standards. This role ensures that QC testing, documentation, and data integrity practices meet established procedures and support product quality and safety

This individual will also be responsible for quality oversight and phase-appropriate cGMP guidance throughout the product lifecycle.

Principal Duties and Responsibilities:

  • Provide QA support for activities associated with site operations, including in-house manufacturing activities as well as those performed at the CDMOs. This also includes activities associated with the distribution of Ocular product through the supply chain workflow.
  • Providing on-floor support during critical processes in manufacturing.
  • Releasing of manufacturing suites and batch/product changeovers for continuation of manufacturing activities.
  • Participating in cross-functional teams to resolve Quality related issues impacting OTX’s operations.
  • Reviewing and approving documentation such as Manufacturing Batch Records (MBRs), product specifications, change controls, deviations and CAPAs associated with the operations at OTX.
  • Participating in Change Control Review Board and providing Quality input and assessment.
  • Perform quality related activities as required within the various Quality Systems including Change Control, Deviation Reporting, CAPA.
  • Authoring, reviewing, and approving internal quality documents (SOPs, investigations, etc.).
  • Supporting 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 control of process.
  • 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 and reports and Stability data.
  • Perform other quality assurance duties as assigned.

Qualifications:

  • Bachelor’s degree in relevant scientific discipline
  • 5+ years of experience in 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
  • Good verbal and written communication skills
  • Strong interpersonal skills and ability to work efficiently on a team
  • Computer literacy, proficiency in MS Office, Excel, PowerPoint etc.
  • Ability to make decisions and resolve issues with minimal guidance

Working Conditions:

  • Office Environment (Primary)
  • Clean Room / Manufacturing Environment (When required to provide on-floor QA support)

 

 

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Salary Range

$109,000 - $121,000 USD

Ocular Therapeutix is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws regarding nondiscrimination. Ocular Therapeutix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or status as a veteran. For information on how Ocular Therapeutix collects, stores, and utilizes candidate information please see our privacy policy found at https://www.ocutx.com/privacy-policy/. For the Privacy Notice for California Job Applicants, please see CCPA Applicant Notice.

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