Ensures that employees are in compliance with their training in accordance with requirements established for each job classification.
Monitors facilities and equipment from a compliance perspective to ensure that the equipment and materials, as well as the facility, are appropriate for aseptic operations.
Reviews Environmental Monitoring documents and ensures completeness and accuracy of the records. Responsible for ensuring that all employees are trained and possess a good working knowledge of the information contained within the training documents.
Develops and performs both classroom and hands-on training of employees. Training programs should include competency evaluations as well as knowledge checks. Regular audits of employee performance to ensure adherence to SOPs. Responsible for notifying and making recommendations to Supervisors for corrective action of any training related employee issue.
Works with a large volume of information applicable to training that needs to be accurate and timely. Must meet deadlines and adhere to training and development schedules.
Position will support Supervisor in developing and coordinating work schedules of employees.
Position will interface with both clients and regulatory agencies and be able to effectively communicate their role in the organization in detail. Position will be responsible for maintaining appropriate reports detailing training for the department.
Ability to understand the impact of their role on the organization and possess the ability to think pro-actively and globally.
Identify opportunities for continuous process improvement both within the department and the organization in order to maintain compliance with cGMPs and regulatory agencies.
Training will not be limited to Environmental Control department but will also be required to conduct training to other departments, as appropriate, as a representative of quality department.
Bachelor’s degree in a science or engineering related field. Bachelor’s degree in Microbiology, preferred.
Minimum 2 years experience in a training capacity coupled with 5 years experience working in an aseptic manufacturing facility.
Experience working in the clean room preferred. Must possess knowledge of proper clean room technique, cGMPs, gowning procedures and operation of filling equipment.
Ability to demonstrate a very strong knowledge of basic cGMP competencies.
Proficiency in the use of Microsoft Office products including project planning techniques and software. Employee will need to work with specialized computer programs for writing and reviewing SOP’s, CAPA’s, and training records.
Must possess excellent interpersonal and communication skills, both written and oral. Must possess the ability communicate in with people at all levels of the organization.
Must be able to organize and maintain multiple responsibilities.