Senior Associate, Quality Systems - Framingham, MA
Company: Replimune Group, Inc.
Posted on: June 6, 2021
Summary of job description
This position 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
- Provide support of day-to-day operations of the Quality System
department for multiple sites and support internal and external
- 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
- 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.
- Highly motivated individual with excellent time management
- Strong organizational skills with the ability to effectively
prioritize and manage multiple projects and tasks with attention to
- Ability to proactively resolve issues in a diplomatic,
flexible, and constructive manner.
- Proficient in Microsoft suite (Word, Excel, PowerPoint, Access
- Excellent written and oral communication skills.
- Ethical, self-motivated and self-directed.
- Bachelor's degree with practical experience in a regulated
manufacturing environment or equivalent experience
- A minimum of 4 years of relevant experience required.
Keywords: Replimune Group, Inc., Framingham , Senior Associate, Quality Systems - Framingham, MA, Other , Framingham, Massachusetts
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