Job Description

The QC Technical Trainer facilitates and conducts on-the-job training for QC personnel; for both the effective induction of new hires into QC as well as, the ongoing improvement and proficiency (i.e. cross-training) of personnel within the department, by delivering on-the-job technical training on a timely basis, including new hire training, QC equipment and basic processes training, cGMP documentation as well as general lab skills training.

ESSENTIAL FUNCTIONS AND RESPONSIBILITES

  • Develops curriculum and analyzes training strategies to identify training requirements and evaluate training effectiveness.

  • Create key training KPIs for senior management.

  • Ensure QC personnel are trained on all the critical documents and there are no gaps in the training curriculum.

  • Demonstrates mastery knowledge of Aseptic Cell Therapy QC method execution.

  • Evaluates job proficiency and skills while correcting and coaching workmanship and technique by completing analyst evaluations or proficiency assessments during QC activities.

  • Actively monitors QC personnel’s technique and application of learning and provides feedback to trainees as well as to managers.

  • Train on specialized Laboratory instrumentation and methods for Appearance, Cell Count, Flow, Elisa, Endotoxin, etc., as applicable, and become an SME for the lab. As an SME assist QC personnel with trouble shooting on the Laboratory instrumentation and/or methods as needed.

  • Ensure the QC personnel are adequately trained on SOP/Method/Work Instruction revisions in a timely manner.

  • Maintains training records and monitors KPIs for Training effectiveness for all QC personnel. Ensure all QC personnel are current on their trainings in QT9.

  • Participates in Audits for training related questions and provides evidence of training for the QC personnel during Client or Regulatory audits.

  • Facilitates timely resolution and closeout of Corrective and Preventive actions specific to Training issues.

  • Partners with the Corporate Training Department to identify technical training needs and design, implement and deploy an effective and comprehensive training program while identifying improvements to the existing training curriculum for QC personnel.

  • Establishes and/or revises technical educational training materials including but not limited to videos, guides, SOPs, LQMs, PMs, and Work Instructions.

  • Coordinates training related to Operational Excellence (OE) initiatives.

  • Participates in and/or contributes to advances Business Process workflow activities (i.e. editing SOPs and training materials).

  • Provides technical writing support for training related processes and procedures.

  • Responsible for managing SOP revisions as well as continually improving the QC training program.

  • Prepares material for new training programs and onboarding aids such as instructional material handouts evaluation forms.

  • Guide and train the new QC hires during the onboarding phase per the curriculum in a phase approach.

  • Stays current on training methodologies and strategies.

QUALIFICATIONS:

  • Bachelor’s Degree in related life science degree and 3+ years of experience in a cGMP Quality Control Laboratory environment

  • Experience in Quality Control with basic knowledge of analytical methods and processes

  • Computer software skills including Microsoft Office.

  • 2+ years of experience in a training role preferred (particularly On-The-Job-Training)

More Details
Employment Type: Full Time
Location: Allendale , New Jersey , United States
Experience Required: Associate
Date Published: 08 Jul 2022
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