The Senior Quality Assurance Training Specialist is responsible for the administration of the Training Department at the Whippany, NJ site, overseeing development and administration of TMS training curricula that provides comprehensive training to employees. This position will also promote compliance and a continuous improvement culture to drive process and cost improvement.
• Responsible for the administration of the Training Department, to ensure adequate training related to the TMS and production of conforming product.
• Takes appropriate actions to inform and educate stakeholders, and revise training procedures and materials as necessary.
• Work with Human Resources and Hiring Managers to establish and maintain a supportive on-boarding program for new hires and transfers.
• Train employees, and contractors alike, to discharge duties as necessary to assure effective company compliance with pharmaceutical and quality system regulations relating to Training and Compliance functions.
• Responsible for oversight and control of training records.
• Work with department managers to improve training programs and training comprehension.
• Establish and support a work environment of continuous improvement that supports the Quality Policy, Quality System and appropriate regulations.
• Provide support during regulatory inspections and client audits as applicable
• Provide inspection readiness support to the site -identification of training compliance gaps and risks, and participation in the remediation process.
• Participate in inspection preparation, and participate in regulatory inspections.
• Strive toward constant improvement of systems in order to maintain compliance cGMP requirements for work performed.
• Review and approve Master Batch Records /Validation Protocols and reports
• Review Annual Product Reviews
• Analyze, implement, adapts, conduct, and evaluate training materials, training courses, and overall training programs related to subject matter areas/topics.
• Assess the quality and effectiveness of training programs for continuous improvement
• Responsible for data collection for training metrics.
• Assist in meeting departmental goals, and special projects as needed.
• Other duties as assigned.
• Demonstrated ability to select, organize, lead, participate and facilitate a team to produce results.
• Ability to multi-task, and handle a number of projects simultaneously in a fast paced environment.
• Proficient in the use of MS Office applications (Excel, Word, Powerpoint) is required.
• Communication (Oral/Written) – Ability to communicate effectively in oral and written form.
• Problem Solving – Ability to find a solution or deal proactively with work related problems. Develops strategies to achieve organizational goals; Understands organization’s strengths & weaknesses; Adapts strategy to changing conditions. Critically evaluates quality systems to propose best practices. Strong problem solving skills and analytical assessment for continuous improvement.
• Interpersonal – Ability to develop and sustain positive relationships with internal as well as external customers.
• Confidentiality – Ability to work with and keep sensitive information confidential
• May be required to move about the facility
• May be required to remain sedentary for periods of time
• May be required to wear personal protective equipment
• Bachelor’s Degree (BA or BS) in Education, Communication, or related discipline
• 5+ years related experience and/or training
• Experience in training in a pharmaceutical company preferred