Trainer, Quality Assurance

Position Summary:  Coordinates, schedules and conducts company-wide training in Quality Assurance and Regulatory Compliance issues assuring company standards, current Good Manufacturing Practices, and the Code of Federal Regulations are known and adhered to and product integrity is preserved.  Functions as an information source to company departments when special and critical quality training issues occur.

 

Scope:  Carries out training responsibilities in accordance with the organization?s policies and procedures.  Adheres to all applicable SOPs.  Function with/in conjunction with all Departments at KOS Pharmaceuticals, Inc.

 

Duties and Responsibilities:

 

?  Conducts all company training in cGMPs, and the quality / compliance-related CFR points.  Ensures that all personnel are made aware of changes in these regulations via periodic training / retraining.

?  Writes / assists in the writing of reports documenting Kos training on quality issues.  Develops methods and systems to document and trend personnel training records.  Works with QA Documentation to properly archive these records.

?  Provides quality-specific training (QA SOPs, etc.) and guidance in the creation of standard training programs for QA and other departments.

?  Acts as system administrator (maintains systems) for the training data base(s).  Provides support / training for the data base(s).

?  Stays abreast of current trends and revisions of these requirements and regulations and implements (if applicable) accordingly.

?  Adheres to all applicable SOPs. Functions in conjunction with Quality Assurance management on special department projects.

Education/Skills and Experience Requirements:

 

The incumbent must have a minimum of a bachelor?s degree preferably in a pharmaceutical industry-related field.  In addition, the incumbent must have a superior working knowledge of training techniques, cGMPs, the CFR (part 21) and be very proficient in Microsoft Office software.  Previous pharmaceutical-industry experience (5+ years) is required; preferably as a Trainer.  Excellent verbal and written communication skills, and the desire to work very closely with all personnel, are essential.

 

 

Job Function Skills:

 

?  Ability to deal confidently and effectively with all levels of employees; to express ideas concisely and in an orderly, disciplined manner - both written and orally.

?  Must enjoy contact with all levels of personal and facilitate a ?give and take? communicative environment; emphasizing inter-personal communications (teaching / learning)

?  Must be able to effectively manage time to meet assigned deadlines.  Must be able to prioritize multiple work assignments.

?  Command of the English language, including excellent grammar skills.

?  Comprehension: Must be able to read and understand written instructions. Must be able to take and carryout verbal instructions.

 

  Apply common sense understanding to carry out instructions.

?  Select from a limited number of solutions the most appropriate action or

procedure in performing the job.

?  Solve practical problems

?  Deal with a variety of concrete variables in situations where only limited

  standardization exists.

?  Interpret a variety of instructions or information furnished in written, oral,

  and diagrammatic or schedule form.



?  Jobs contain a variety of tasks and duties.

?  Activities typically do not deviate from standard practices and procedures.

? Individuals may be permitted to set their own priorities, subject to the supervisor?s approval.

? Determine their own priorities.

? May deviate from established procedures and practices as long as the end results meet standards of acceptability.

 

 ?  Software:

o MS-Word

o MS-Excel

o MS-Access

o MS PowerPoint