iSixSigma

Quality Assurance, Training Specialist (Lead)

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Thermo Fisher - America
Published
June 2, 2021
Location
Carlsbad, CA
Job Type

Description

This role is responsible for Training management of a recently built enzyme manufacturing facility serving pharmaceutical customers. This operation is part of our Biosciences Division (BID), part of our Life Sciences Solutions Group (LSG). BID is experiencing outstanding growth supporting exciting markets: Academia, Research, Biotech, Pharma, Cell and Gene Therapy and Medical Devices.

How will you make an impact?

The Training Lead will be responsible for defining, implementing, maintaining and continuously improving a robust training program. This will include using expert knowledge to create and maintain Competency Based Leading (CBL), Onboarding programs, On-the-Job trainings (OJTs) as well as managing manufacturing process training materials.

What will you do?

  • Utilizes knowledge of manufacturing procedures, processes and theory to identify and resolve training/knowledge issues, enhance training program and improve training effectiveness.
  • Collaborate with other Thermo Fisher sites for development, alignment and implementation of training processes.
  • Partner with manufacturing leadership to establish training curriculum structures and strategies.
  • Review department’s training documentation for compliance with Training SOPs and Good Documentation Practice (GDP), generate curriculum forms, and develop content for OJTs and training runs.
  • Schedule and coordinate training activities for department; deliver training or coordinate delivery of training with qualified trainers.
  • Coaches/mentors department trainers; develops and maintains efficient process for qualifying trainers.
  • Create training reports and generates KPI metrics and trends.
  • Drive a culture of continuous improvement by employing Practical Process Improvement concepts and reporting metrics and communicating internally to diverse audiences.
  • Perform other duties as assigned.

How will you get here?

Education

  • Bachelor’s degree from an accredited college/university with a preference for Science, Engineering, Biochemistry, Biotechnology, Biology or Biomedical Engineering.

Experience

  • Minimum of 3-5 years’ experience within the Medical Device or Pharmaceutical Industry supporting Regulated Products. Must have a minimum of two (2) years direct training experience.
  • Solid understanding of GMP guidance, including 21 CFR Part 11, and Annex 11.
  • Prefer hands-on industry experience in cGMP/Biotech/Biopharmaceutical/FDA regulated industries.
  • Experience with and knowledge of related quality systems such as Change Control; CAPA (including: Deviations/OOSs); and Document Control is required.

Knowledge, Skills, Abilities (Required)

  • Knowledge of global regulations (e.g., FDA 21 CFR Part 11, EudraLex Volume 4 Annex 11 etc.) and guidelines (e.g. FDA, MHRA Data integrity guidelines, etc.) around quality systems in Biotech and/or Pharmaceutical industry
  • Excellent communication and listening skills
  • Ability to build and maintain strong collaborative relationships across multiple departments
  • Microsoft Office and database management skills
  • Position requires knowledge of Current Good Manufacturing Practices (cGMPs) and FDA/industry regulations.

Knowledge, Skills, Abilities (Preferred)

  • Experience with biological manufacturing processes.
  • Advanced Project Management experience.
  • Certified Lean Professional or Six Sigma
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