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Manufacturing Training Associate II/III
Posted on 7/28/2022
INACTIVE
Locations
Bothell, WA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Leadership
Management
Requirements
  • Bachelors in relevant science or engineering discipline, or equivalent in work experience
  • 2+ years of experience in cGMP manufacturing, experience in cell therapy manufacturing required
  • Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing
  • Exhibits a strong understanding of aseptic technique and cleanroom etiquette
  • Demonstrates strong Good Documentation Practices (GDP)
  • Must have experience performing Environmental Monitoring (EM) and knowledge of EM principles
  • Ability to work independently to meet objectives and perform with a high degree of accuracy. Exhibits leadership behaviors including collaborating for results and developing/executing strategy
  • Demonstrates proficiency in written and verbal communication
  • Experience working with Subject Matter Experts and translating content and performance requirements into sound training content
  • Ability to coordinate, contribute to and work within a cross-functional team
  • Ability to receive and provide feedback in a constructive way
  • Ability to maintain collaborative professional relationships with colleagues, peers and all levels of management and with various stakeholder departments
  • Ability to thrive in a dynamic and fast-paced environment
  • Must possess the ability to take initiative to complete assignments and job responsibilities with minimal supervision
Responsibilities
  • Follows safety requirements and completes safety trainings and escalates safety concerns
  • Recognizes and escalates potential deviations to management
  • Assists in the development and implementation of a comprehensive, competency-based, high-quality manufacturing training program
  • Schedules training tasks for Manufacturing new-hires
  • Trains staff on cGMP manufacturing operations per On-the-Job training, standard operating procedures, batch records, and work instructions. Lead Instructor Led Classes under supervision
  • Ensures trainees perform tasks in a manner consistent with safety policies, quality systems, and cGMP requirements
  • Train best practices and processes related to a comprehensive on the job training program
  • Promotes a high energy, positive, and collaborative culture. Assists in setting-up and maintaining the manufacturing training area(s)
  • Reviews manufacturing documents for ease of understanding, technical soundness, effective and efficient operations, and cGMP compliance
  • Ensures that all training documentation is accurate, complete, and available for review by management or regulatory agencies
  • Applies continuous improvement to the training program
  • Collaborates with department managers, supervisors, and trainers on an on-going basis to prioritize training needs and to verify the effectiveness of the training program
  • Acts as a Subject Matter Expert in the Learning Management System
  • Participate on department teams
Bristol-Myers Squibb

10,001+ employees

Biopharmaceutical development company
Company Overview
Bristol-Myers Squibb engages in the discovery, development, licensing, manufacturing, marketing, distribution and sale of pharmaceuticals.