Quality Training Specialist

POSITION DETAILS Position Title: Training Specialist Function: Quality Reports To: Director, Corporate Quality Systems Location: Marietta, GA POSITION OVERVIEW The Training Specialist’s role is to provide continuous coaching and training to Osmotica, Alliant, and the Corporate personnel to assure GMP regulations are understood and being followed.

The trainer has responsibility for the facilitation of cGMP-related learning and development programs and assisting functional areas with developing competency training. The Trainer supports OJT Certification, associate development, orientation/on-boarding (New Hire Orientation), and procedure training materials development, etc.

The Training Specialist is responsible for coaching departments in the development of all training plans per position and monitoring routine review of plans to ensure continuous accuracy and improvement.

DUTIES AND RESPONSIBILITIES

Enhance Operations & Quality organizational effectiveness and performance through the selection, development, execution, and maintenance of learning solutions and content Facilitate cGMP related learning: Develop or source training programs to meet specific training needs Present and/or recruit knowledgeable experts, as appropriate, to perform scheduled training Conduct cGMP and New Hire Orientation learning sessions in both group and one-on-one settings Conduct Annual GMP training for all departments.

Plan and develop Annual GMP competency assessments for personnel Collaborate with department managers to assess training needs and identify skill gaps Serve as internal subject matter expert for creating/facilitating training matrices and curriculum Assist instructors and SMEs in scheduling of training events and programs.

Prepare/Arrange for training materials, hand-outs and other instructional aids Compile periodic reports of training opportunities and action steps needed for learning and improvement Perform additional duties and responsibilities as assigned EXPERIENCE AND QUALIFICATIONS Bachelor’s degree in education or a science-related field preferred 2+ years’ experience developing, teaching, and/or facilitation of quality compliance and other learning programs Strong presentation and facilitation skills with the ability to engage employees and stakeholders at all levels Effective written and verbal communication skills with the ability to match content with end user functionality; including ability to communicate with all levels of staff and management Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information Frequently interacts with others.

Must have an outgoing personality and skills in speaking, organizing, listening, leadership, communication, and decision making Ability to organize and adapt to organization priority changes and work effectively with minimal supervision / independently with a sense of urgency Preferred Experience / Skills Knowledge of pharmaceutical production and application of c.

GxP regulations Experience with learning management systems (LMS) Experience in developing and conducting Train-the-Trainer training sessions OTHER REQUIREMENTS 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 the job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the essential duties of this job the employee is frequently required to stand, walk, and reach with hands and arms. Employee may be required to inspect pharmaceutical equipment which includes crouching to look under equipment and/or contorting to examine difficult to view areas.

The employee is regularly required to sit, use the hands and fingers to type via the use of the PC (Personal Computer). Must be able to lift and move up to 20 lbs. Periodic/infrequent travel to sister sites may be required. No Personal Protective equipment required, unless entering in-process production areas. The above statements are intended to describe the general nature and level of work being performed.

They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.