Senior Associate, Quality Assurance

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.
• 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).
• 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
• Familiarity with analytical testing and laboratory workflows
• Understanding of 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