Quality Assurance Training Specialist

SUMMARY:

This position will be responsible for the design and implementation of GMP training curriculum(s) for designated areas within Sharp Commercial US. 

Responsibilities include adherence to and enforcement of GMP compliance, training of designated peers at management request, managing the Sharp Commercial - US GMP training program, providing hands on and on the job training, maintaining training documents and ensuring training records are up-to-date and ready for regulatory inspections.

Training has a direct impact on company compliance with regulatory requirements and customer satisfaction.

ESSENTIAL DUTIES AND RESPONSIBILITIES: The following is a list of minimum responsibilities for the Training Specialist.  Other duties may also be assigned.

• Responsible to work with designated areas(s) to identify critical job roles and/or tasks requiring training.  Design curriculums for identified roles, define training requirements for each curriculum and design qualification requirements, criteria, and assessments for associated curriculums. 
• Perform administrative tasks within the QMS for the training module (including but not limited to assigning learner roles, adding or removing items from learner roles, creating training requirements, etc.)
• Work with other training specialists to develop processes and best practices for managing the GMP training program.
• Work with the training specialist to develop process and best practices for maintenance and update of the GMP training program for new and existing staff according to cGMP’s and Sharp procedures.

Phase I Orientation which includes but is not limited to:

• SOP Training. Facility Tour. Proficiency Training.

Phase II Training which includes but it not limited to:

• SOP Training. Proficiency Training.

Qualifications which include, but are not limited to:

• Staging Verification. AQL Verification and Label Verification. Cleaning Verification. Reconciliation. Calculations.
• Responsible for maintaining Training program and training records in an inspection ready state.
• Responsible for identifying 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 providing periodic training status updates and reports.
• Responsible for coordinating internal meetings/training with Supervisors.
• Must be flexible to meet the needs of the organization relative to off shift training when required.

SUPERVISORY RESPONSIBILITIES:

N/A

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.

EDUCATION and/or EXPERIENCE:

Associate or bachelor’s degree is preferred with one to four years related experience, a minimum of (2) Certificates of basic quality skills and practices and/or training or a High School Degree with four to six years related experience and/or training; Experience in inspection of Pharmaceutical or related industry is required.  Outside certification of basic quality skills and practices (i.e. ASQ, CQIA, CQI, CQT, etc.) is desirable.

• 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.
• A positive work attitude that supports teamwork and continuous improvement.
• Excellent interpersonal communication skills and presentation skills with personnel from multiple departments and responsibility levels.
• Equipment Knowledge:
• Equipment and Tooling Identification Proper Calibration Status

MATHEMATICAL SKILLS:

Ability to apply moderately complex mathematical operations including an understanding of statistical sampling plans and the ability to calculate time, percentages, and decimals.  Basic math skills (addition, subtraction, multiplication, and division) are required.

LANGUAGE SKILLS:

Ability to effectively communicate (written or verbally) with the following groups:

Internal: Daily contact with Quality Department and Operations Department employees for information on training related issues and cGMP issues.

External: Occasional contact with customers and regulatory agencies on personnel training related issues and cGMP issues.

WRITTEN SKILLS:

Ability to provide clear, concise, and legible documentation within the batch record and/or memos to file in conformance with basic Good Documentation Practices.

REASONING ABILITY:

The ability to make rational decisions pertaining to quality compliance is required.  Ability to resolve problems effectively and efficiently.

COMPUTER SKILLS:

Basic Windows applications include Microsoft Office Suite.

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.