cGMP Trainer

SUMMARY

Plans, implements, evaluates, and documents all GMP training activities and reinforcement programs to assure compliance with company objectives and GMP regulations.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES

Coordinates the scheduling of GMP training programs for new and current employees.  Works with the HR Department for new employees.

 

Audits training records for cGMP compliance.  May also audit the facility, personnel and plant activities for compliance with cGMPs. 

 

Assists line management in planning, conducting, evaluating, and documenting all GMP training programs.

 

Coordinates the development and distribution of GMP reinforcement materials to various departments and individual supervisors.

 

Coordinates the availability and proper functioning of all audio-visual materials and equipment.

 

Communicates with QA management, Plant management, and BPI associates (outside training consultants) on the development and presentation of training lessons, books, seminars, and programs.

 

Maintains a library of GMP training programs and materials.

 

Utilizes current company communications strategies to reinforce GMP awareness on a continuing basis.  Facilitates GMP awareness in department meetings using discussion and videotapes.

 

Provides monthly reports to QA Manager summarizing activities during each month.  Meets with QA Manager every two weeks for face-to-face meeting.

 

May perform other reasonable, related business duties.

 

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  Additionally, an individual must uphold the standards of conduct of the company, which include confidentiality, cooperation, and respect for people and property.  The requirements listed below are representative of the knowledge, skill, and/or ability required.

 

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

EDUCATION AND EXPERIENCE:

BS/BA

 

LANGUAGE SKILLS:

Ability to write reports, business correspondence, standard operating procedures, and procedure manuals.  Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.  Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.  Ability to effectively present information to top management, public groups, and/or boards of directors.

Ability to read, analyze and interpret the most complex documents.  Ability to respond effectively to the most sensitive inquiries or complaints. 

 

MATHEMATICAL SKILLS:

Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.

Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume.  Ability to apply concepts of basic algebra and geometry.

 

REASONING ABILITY:

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.  Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. 

 

OTHER SKILLS AND ABILITIES:

Ability to use a PC and the following software:  Microsoft Office suite and Access.

 

CERTIFICATES, LICENSES, REGISTRATIONS

Certificates from GMP training programs.

 

SPECIAL REQUIREMENTS

Must meet applicable DEA security clearance 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 function.

 

While performing the essential duties of this job, the employee is occasionally required to climb or balance, stoop, kneel, or crouch, and reach with hands and arms.  The employee is frequently required to sit.  The employee is regularly required to stand, walk, use hands to finger, feel, or handle, and talk/hear/listen.  The employee occasionally may push/pull/lift/carry up to 10 pounds.  There are no special vision requirements.

 

 WORK ENVIRONMENT

The noise level may vary from quiet to moderate.

 

PERSONAL PROTECTIVE EQUIPMENT

No PPE required unless entering production areas.