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AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Quality Trainer II

Branchburg Township, New Jersey Req ID 2207765 Category Human Resources Division AbbVie

 

Under the supervision of Quality Training management, the Quality Training Analyst II will support all aspects of the site training processes which include but not limited to the activities listed below. Complies with FDA, ISO, AATB, and all other applicable international, national and state regulatory requirements, best industry practices, AbbVie corporate and internal processes. Compile Quality metrics for QSMR, Tier board etc. and identify and bring issues to management when a compliance gap or quality issue is identified.

 

  1. Support the Site Training program to ensure it meets all applicable regulatory requirements and is aligned with corporate policies.
  2. Support training management and cross functional areas to ensure the overall effectiveness of the site training program.
  3. Compile Quality metrics for QSMR, Tier board etc. Support projects and identify and bring compliance gap or quality issue and improvement opportunities to management.
  4. Support Change Control process to identify affected training curriculums and ensure proper trainings are assigned and the trainings are effective

 

 

 

KEY DUTIES AND RESPONSIBILITIES: Describe scope:

% of Time or

Importance

Support the Site Training program to ensure it meets all applicable regulatory requirements and is aligned with corporate policies.

  • Conduct gap assessment of site training processes as assigned per applicable regulatory requirements. Resolve any compliance gaps identified.
  • Support the integration of site training program into AbbVie. Support the integration GAP assessment for training procedures and processes and ensure site training procedures are aligned with corporate policies/processes and comply with site specific regulatory requirements.
  • Support the development and of functional integration quality plan and/or change control per corporate requirements and timeline.
  • Act as functional SME during internal audits and external audits. Identify and propose process improvement opportunities.
  • Partner with Corporate to provide site support and implementation on initiatives, system upgrades, projects and procedure changes.
  • Maintain the site electronic Learning Management System (ComplianceWire)
  • Work with IT to and Corporate Training team to troubleshoot and resolve ComplianceWire issues, as necessary.

 

30%

Support training management and cross functional areas to ensure the overall effectiveness of the site training program.

  • Support training management and cross functional areas to apply the best practices and identify improvement opportunities to site training program.
  • Support cross functional areas to ensure all employees, including temporary employees, consultants and contractors who conduct GMP work have appropriate training plans in place; and appropriate training plans are developed for new hires and all required personnel quality records (i.e., Job descriptions and CVs) are put in place.
  • Support Operations training teams in developing training materials to improve site quality culture and reduce human error NCRs.
  • Managing daily activities related to training.
  • Support the site annual training plan review process and ensure all cross functional management complete the annual training plan review for their employees as required.
  • Coordinate site Integration leads to assign corporate procedures/policies to affected site personnel as required.
  • Create custom curricula based on business requirements and employee needs. Partner with cross functional management and corporate to implement proper training to support site and corporate initiatives and projects

40%

Compile Quality metrics for QSMR, Tier board etc. Support projects and identify and bring compliance gap or quality issue and improvement opportunities to management:

  • Compile and report training metrics for QSMR, site tier 2 and Tier 3. Track key performance indicators to drive learning and process improvement. Support training management to drive training initiatives, implement learning technologies and implement process improvement.
  • Monitor site training metrics to ensure all functional areas within the site are effectively engaged in completing the assigned training. Escalate late training assignments to management/site tier meetings as needed.
  • Create custom weekly and monthly training reports as needed for managers to ensure training compliance.
  • Participate/lead training related project teams to ensure timely completion of project with quality. Report project status to upper management as needed.
  • Coach junior team members in the creation, monitoring of training metrics

15%

Support Change Control process to identify affected training curriculums and ensure proper trainings are assigned and the trainings are effective

  • Review and approve training strategies for upcoming change controls to ensure proper means are used for training
  • Review DCCs to ensure required training are assigned
  • Measure training effectiveness as needed post implementation to ensure continued and measurable success of the implemented projects/process changes
  • Develop criteria to evaluate the effectiveness of training activities, including but not limited to quizzes, surveys and process confirmation observations.

 

15%

Qualifications:

Education and Experience

  • BA or BS Degree, or equivalent experience preferred
  • 3+ years of Training experience in Medical Device, Pharmaceutical, Human Tissue or Biotech industry is preferred.
  • Familiar with Microsoft Office Applications including Word, Excel, PowerPoint and Outlook.
  • Ability to work on cross functional teams and apply influencing skills in a matrix environment along with the ability to partner with and influence key internal and external stakeholders.
  • Experience with training content development and associated programs/technology.
  • Experience with working and managing electronic learning management systems (LMS).
  • Ability to aseptically gown and work in a controlled processing environment working with human and animal tissues.
  • Knowledge of manufacturing concepts such as GxP, 5S and visual management systems etc.
Significant Work Activities: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: No
Job Type: Experienced
Schedule: Full-time
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