Job Description

POSITION SUMMARY:

The Training Coordinator will support the Quality Assurance Department by assisting in the development and maintenance of the Training Program. The Training Coordinator will be responsible for working with the Functional Departments in establishing the training curriculum, monitor the training, and re-training.

DUTIES AND RESPONSIBILITIES:

• Develop a Train the Trainer Program.
• Assist with the delivery of group and or individual training.
• Conduct basic Good Documentation Practice (GDP) and Good Manufacturing Practice (GMP) training.
• Review and share the training status report, metrics with the Management Team.
• Partner with the Human Resources Department in managing the new employees Onboarding process and/or department transfer.
• Oversee and coordinate the work of departmental Qualified Trainers.
• Work with the Qualified Trainers in identifying the opportunities for improving the Training Program.
• Support the development of training guides and slide presentations.
• Support internal and external audits.
• Additional duties as assigned.

EDUCATION AND EXPERIENCE:

• BS/BA degree in a scientific/life sciences discipline.
• A minimum of four (4) years of progressive QA experience in a pharma/bipharma environment or related regulated industry, preferably with 2 years of training management experience.
• Knowledge of principles and practices of CGMP.
• Knowledge of FDA, EMA and ICH guidelines.
• Experience in QA support of biologics manufacturing and compliance; experience in Gene Therapy and/or Cell Therapy is a plus.
• Experience in a commercial CGMP environment is a plus.

DESIRED KEY COMPETENCIES:

• Ability to understand and execute the company’s mission and values.
• Exceptional organizational skills with strong attention to detail.
• Strong interpersonal skills including clear communication in both oral and written form.
• Demonstrated ability to work with and coordinate demands from multiple stakeholders.
• Exhibition of the highest degree of ethical standards and trustworthiness.
• Ability to maintain a professional and pleasant demeanor.
• Ability to learn then administer automated quality systems; experience with Veeva is a plus.
• Responsive, can-do attitude.
• Deals with conflict in a direct, positive manner.

EOE MFDV

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