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Senior Associate, Quality Assurance

Department: Quality Assurance
Reports to: Manager, Quality Assurance
Location: Framingham MFG Office

Summary of Job Description:
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.

Key Responsibilities

  • Provide supporting day-to-day operation of the Quality Assurance department
  • Operate in accordance to GMP
  • Initiate, review and process deviations, CAPAs, and change controls
  • Conduct / participate in internal and external audits
  • Collate and review manufacturing and testing records
  • Allocate unique identifier reference numbers to documents
  • Issue and publish documents
  • Archive documents
  • Review, track and trend deviations, change controls, both internal and external
  • Assist in populating QMS metrics
  • Manage and store all staff training records.
  • Provide support to all Replimune internal and external customers.
  • Adhere to company documentation policies and maintaining documentation systems as required.

Other responsibilities

  • Support Clinical QA activities.
  • 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.
  • Other duties, as assigned.

Educational Requirements

  • A minimum of a college degree.

Experience and Skill Requirement

  • A highly motivated individual, with excellent time management.
  • Organized and methodical approach to tasks.
  • IT skills – competent in using Microsoft Office.
  • A level of flexibility is essential to meet varying workloads.


EEO & Employment Eligibility:

Replimune is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, ancestry origin, disability or veteran status. Replimune also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

Recruitment/Staffing Agencies:

Replimune, Inc. does not accept agency resumes unless contacted directly by internal Replimune Talent Acquisition. Please do not forward resumes to our careers site, employees or any other company location of Replimune. Replimune will not be responsible for any fees related to unsolicited resumes.