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Operations Training Specialist II

March 11 2022
Categories HR, Training, Optical, Production, Operations, Quality, Safety, Training - Development - Improvement
Whitby, ON

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

How will you make an impact?
Monitoring and directing training activities, developing training material, leading training sessions, creating training metrics and supporting Deviation Reports(DR)/ Corrective Action Preventative Action (CAPA)
initiatives within the operations department.

What will you do?

Standard Operating Procedures (SOPs) & Hands-On Training

  • Reviews, revises and prepares procedures/Standard Operating Procedures (SOPs) for compliance to Good Manufacturing Practices (GMP) and to reflect current work activities in Operations department
  • Ensures procedures/SOPs for Operations department are of sufficient detail for technical content, accuracy, clarity, completeness, and flow. In particular, procedures in response to Bi-Annual Reviews, DRs, comments/audits by clients and regulatory agencies, change controls (CCs), new/modified equipment, and general changes in procedures
  • Ensures procedures/SOPs are regularly reviewed and kept up to date with proper approvals
  • Works closely with Compliance Department to ensure SOPs are reviewed and revised appropriately and training is provided
  • Develops training material and leads training sessions for Operations staff

Training and Process Improvements

  • Prepares materials for informal and formal training
  • Assesses the learning styles and requirements of employees within Operations department and to design evaluation methods
  • Coordinates, conducts and documents training sessions as required
  • Works with Operations Personnel to identify training and process improvements
  • Analyzes training-related efficiency in the different work centres
  • Supporting DRs/CAPAs
  • Works closely with Operations team to support related investigations
  • Helps support investigations and determine the root cause as required
  • Proposes CAPA to training related deviations
  • Manages the Operations trending tool to help validate identification and elimination of root cause
  • Follows up on CAPA actions and own the responsibility of keeping the follow up actions current
  • Supports all CAPA related training activities for operations team

Training Metrics

  • Collects and analyzes Operations training metrics and identify potential projects/solutions
  • Accepts Operations related DRs in order to initiate and lead the investigation and the appropriate parties
  • Prepares problem solving strategies

How will you get here?
Education:

  • Bachelors of Science or Bachelor of Applied Science or related field

Experience:

  • Minimum 3 years of related pharmaceutical experience, preferably in a Manufacturing environment
  • Minimum 1 year of previous training experience in the pharmaceutical industry.

Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.

Competencies:
Full knowledge of cGMP requirements and pharmaceutical processing regulations. Proven ability to coach and develop staff as well as the technical ability to coordinate departmental business activities. Strong leadership, team building and organization skills. Excellent computer skills, including the ability to develop spreadsheets, presentations and reports. Superior written and oral skills. Detail oriented and organized, with a high degree of accuracy and thoroughness. Previous training experience, preferably in the pharmaceutical industry. Excellent interpersonal skills. Proficiency with Microsoft Office. Proficiency with the English language. Previous experience in problem solving (identifying and evaluating problems, and recommending corrective actions / preventative actions (CAPA).

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

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