Senior Associate, Quality Assurance

Replimune•Framingham, MA

About The Position

This position will be required to interact with all departments within the company and to proactively support GMP compliance. The role provides an opportunity to enhance quality skills and experience within a GMP environment.

Requirements

3-5 years of quality experience in biotech or pharmaceutical industry.
High level of attention to details and excellent time management.
A very organised and methodical approach to tasks.
Strong written and verbal communication skills to interact with other functions.
IT skills – competent in using Microsoft Office.
A level of flexibility is essential to meet varying workloads.

Responsibilities

Provide supporting day-to-day operation of the Quality Assurance department to ensure the implementation and maintenance of Quality Management System (QMS) in accordance with applicable standards established by FDA, MHRA, and other regulatory bodies.
Aid in preparation for inspection readiness and participate actively during inspections and audits.
Perform batch release for GMP lots, including final Quality Review of associated quality records to ensure closure, preparation of associated batch release documentation to ensure completeness and accuracy in accordance with procedure.
Prioritize batch release in support of business needs including maintaining batch release status and communicate release needs throughout the organization.
Support the oversight of Replimune GMP compliance and Quality systems: change control, deviation, and corrective and preventive action (CAPA) systems including support of thorough root cause analysis investigations related to quality issues.
Assist in tracking and populating QMS metrics related to change controls, CAPAs and deviations.
Conduct / participate in the Change Control Review Board
Support vendor qualification process, issuance of vendor questionnaire and authoring of vendor quality technical agreements.
Support supplier corrective action notification and request, vendor notification systems, when applicable.
Review and approve Standard Operating Procedures (SOPs), Validation Protocols / Reports, Production Records, or GMP records, Testing Records and Engineering Drawings, ensuring internal and external standards are met.
Interface and provide support to internal customers in Product Development, Quality Control Labs, etc., and, as appropriate, with external vendors to support ongoing compliance with Replimune requirements and quality standards.
Drafts, reviews, provides oversight to content, and approves controlled documents which may include but is not limited to standard operating procedures, validation documents, material specifications, etc.
Work cross functionally with Quality Assurance, Quality Control, Regulatory and Clinical groups to ensure commercial readiness for licensure