Senior Associate, Quality Systems

3 weeks ago

Framingham, United States Replimune, Inc. Full time
Overview

The Sr. Associate, Quality Systems, provides cross-functional support of GXP activities as they relate to Quality Systems. This position will participate in the improvement of Quality Systems to ensure quality and adherence with current Good Manufacturing Practice (cGMP) and inspection readiness.

This position is based in our Framingham, MA facility, and has a 4-5 day in office requiremet per week.

Responsibilities

Key responsibilities:
  • Provide support of day-to-day operations of the Quality System department for multiple sites and support internal and external customers.
  • Participate in continuous improvement initiatives.
  • Review records and documents, for completeness and compliance with global regulations.
  • Generate standard operating procedures and/or guidelines to define and improve quality system functions.
  • Support and manage document lifecycle the Electronic Document Management System (EDMS).
  • Track and trend compliance paperwork (deviations, change controls, etc. both internal and external).
  • Oversee training documentation and compliance metrics through use of learning management system (LMS).
  • Assist with employee "on-boarding" training on general quality specific procedural requirements.
  • Ensure organizational charts are updated on a regular basis.
  • Participate in the internal audit program.
  • Create and modify user groups, training items, curricula, group trainings and assignments.
  • Conduct periodic review and audits of Quality Systems.
  • Assist with preparation of QMS metrics.
Qualifications

JOB REQUIREMENTS:
  • Highly motivated individual with excellent time management skills.
  • Strong organizational skills with the ability to effectively prioritize and manage multiple projects and tasks with attention to detail.
  • Ability to proactively resolve issues in a diplomatic, flexible, and constructive manner.
  • Proficient in Microsoft suite (Word, Excel, PowerPoint, Access and Outlook).
  • Excellent written and oral communication skills.
  • Ethical, self-motivated and self-directed.
Educational requirements:
  • Bachelor's degree with practical experience in a regulated manufacturing environment or equivalent experience
  • A minimum of 4 years of relevant experience required.


This position is based in our Framingham, MA facility, and has a 4-5 day in office requiremet per week.

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