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Senior Specialist
Quality Assurance Training
Posted on 8/16/2022
INACTIVE
Locations
Bothell, WA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Management
Research
Requirements
  • 5-8 years of relevant cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals, cell therapy manufacturing, or quality control is preferred
  • Experience working with Subject Matter Experts and translating content and performance requirements into sound training content
  • Knowledge of adult learning methods, strategies, and techniques
  • Excellent written, verbal, and presentation skills
  • Strong communication, analytical, and problem-solving skills
  • While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings
  • May work in areas with exposure to vapor phase liquid nitrogen and other chemicals
  • Must be able to gown per requirements to enter manufacturing space
  • Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include, but not limited to safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hairnets, gloves, and hearing protection
Responsibilities
  • Maintain, evolve, and improve the training lifecycle program for QA Ops On-The-FloorTF Team to ensure compliance with approved procedures
  • Support and lead the training and on-boarding of all QA associates for the QA Ops On-The-Floor Team for all tasks including but not limited to facilitating system access, navigation of systems, batch record review, product receipt, product packaging, gowning, deviations, and document review
  • Support and own necessary change control and CAPA actions related to revision of training procedures and curriculums
  • Own, Revise, and Approve Standard operating Procedures and training documents as needed
  • Conduct Quality on the Floor activities including quality walk-throughs of the manufacturing, QC areas, and warehouse locations
  • Act as QA Subject Matter Expert (SME) and support cross functional groups on root cause analysis and development of corresponding corrective and preventive actions
  • Lead small to large scope projects as assigned
  • Participate in small and large cross functional project groups as QA Subject Matter Expert (SME), related to training
  • Support internal and external audits, including documenting observations and oversee implementation of corresponding CAPAs
  • May provide support to QA Ops OTF department when available and participate in tasks including but not limited to batch record review, product receipt, product packaging, deviations, and document reviews
  • May Own, Review, and approve deviations, product non-conformities, and GMP investigations to ensure adequate resolution and compliance with current Good Manufacturing Practices (GMPs)
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.