Our Cell & Gene Therapy Biotechnology Client is seeking a QC Technical Trainer who will facilitate and conduct 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.

• 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.

REQUIREMENTS

• Bachelor’s Degree in related life science degree
• 3+ years 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)
• Highly organized and capable of successfully managing multiple priorities using effective time management techniques.
• Problem Solving, Analysis, and Business Acumen.
• Maintain accurate documentation and records.
• Written and oral communication skills in English
• Excellent presentation skills with the ability to communicate effectively.
• Must be accountable for work product and have strong work ethic.
• May indirectly supervise other technical trainers.

While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen.

Non-absorbent laboratory coats are required, as well as latex (or a non-latex substitute) gloves. When working with potentially hazardous materials that may spray, aerosol, or otherwise contact skin or mucous membranes, face shields or goggles must be worn

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey.

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