QA Label Technician (2nd shift)

SUMMARY:

Responsibilities include preparation, inspection, documentation and distribution of labels used during the packaging process. Proficiency in the use of computer systems and printer use and maintenance are also required. Must have the ability to prioritize the printing of label and a critical detailed review of each run. Additionally, participation in internal, external or regulatory audits will be required at the discretion of senior management.

Scope of the position includes all Sharp facilities. The impact of label printing could expose the company to significant risks or economic loss.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

The following is a list of minimum responsibilities related to the Label Technician position. Other duties may also be assigned.

Responsible for preparation of internal labels associated with in-process work and component identification.

Responsible for the preparation of finished labels associated with clinicals, pallet identification and finished products.

Responsible for documented evaluation of all labels.

Responsible for use of the associated printers as applicable to the specific label run.

Responsible for minor maintenance of the printers used for all label runs.

Responsible for verification of clearance of label printers prior to proceeding to the next label run.

Responsible for training of designated peers as a replacement. This is completed at

management’s request.

Responsible for ordering labeling supplies as required to assure functionality of the label room is not impacted.

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:

None

PREFERRED / REQUIRED EDUCATION and/or EXPERIENCE:

Associates or bachelor’s is required with two to four years related experience and/or training, or High School Degree with four to six years related experience and/or training. Experience in label generation for pharmaceutical or related industry is desired.

• General knowledge of FDA regulations related to cGMPs.

• General knowledge of quality control/assurance.

• Good documentation and communication skills

• Good organizational and planning skills

- Knowledge in the use of Microsoft Office Suite

- Knowledge in the use of label generation software, i.e. EasyLabel

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. The employee must occasionally lift and/or move up to 10 pounds. 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.

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.