What are the responsibilities and job description for the QA Training Manager position at Sharp Clinical Services?
SUMMARY:
This position will be responsible for the oversight of the GMP training team through the design, implementation, maintenance, and continual improvement of the GMP training program for all Sharp Commercial US sites.
Responsibilities include adherence to and enforcement of GMP compliance, ownership of the GMP training program and maintaining a state of inspection readiness.
This position is responsible for developing metrics, dashboards, and reporting to maintain compliance and improve user experience with respect to training.
Training has a direct impact on company compliance with regulatory requirements and customer satisfaction. This position will be accountable for supporting regulatory and customer inspections related to the GMP training program and the training portion of the Quality Management System.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
The following is a list of minimum responsibilities for the Training Manager. Other duties may also be assigned
Responsible for working with a variety of departments to identify critical job roles and/or tasks requiring training and design curriculums, training requirements and qualification requirements for identified roles.
Work with the team of training specialists to develop processes and best practices for building, managing, and continually improving GMP training program for new and existing staff according to cGMP’s and in alignment with Sharp’s Global Training Standard.
Supports the onboarding and implementation of a new training module in the quality management system and becomes a subject matter expert with respect to the system.
Responsible to maintain the GMP training program in an inspection ready state.
Responsible to identify training gaps through critical review and assessment of current training processes for effectiveness and making modifications to training curriculum and qualification requirements to improve demonstrated effectiveness.
Responsible for the ownership for standard operating procedures (SOPs), work instructions (WRKIs), and training materials (TMs) relative to the GMP training program.
Responsible to serve as the point of escalation for the training team to remove roadblocks and drive actions to completion.
Must be flexible to meet the needs of the organization relative to off shift training when required.
QUALIFICATIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
SUPERVISORY RESPONSIBILITIES:
Directly supervises a team of training specialists supporting the build and improvement of training program and processes across three sites. Prioritizes work and helps to reallocate resources on behalf of the entire group in line with business needs.
PREFERRED / REQUIRED EDUCATION and/or EXPERIENCE:
An Associates or Bachelors degree is preferred with a minimum of six years related experience a minimum of (2) Certificates of basic quality skills and practices and/or training or a High School Degree with a minimum of ten years related experience and/or training; Experience in training in pharmaceutical or related industry is required. Outside certification of basic quality skills and practices (i.e. ASQ, CQIA, CQI, CQT, etc.) is preferred.
- Good Documentation Practices Skills
- Demonstrated ability to design training materials and deliver interactive training.
- Excellent verbal and written skills
- Ability to simultaneously manage multiple tasks.
- Ability to work flexible hours.
- Positive work attitude that supports teamwork and continuous improvement.
- Excellent interpersonal communication skills and presentation skills with personnel from multiple departments and responsibility levels.
PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel and talk or hear. The employee frequently is required to sit. The employee is occasionally required to stand, walk, and reach with hands and arms. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is normally required to sit at a desk or periodically go onto the shop floor. The working environment is clean and not normally subject to hazardous environment or conditions.
The individual must be able to speak publicly and deliver training to a variety of group sizes and compositions.
DISCLAIMER:
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.
