QA Label and Verification Associate
2 weeks ago
Responsibilities include preparation, inspection, documentation and distribution of labels used during the packaging process. Proficient in 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 risk or economic loss.
ESSENTIAL DUTIES AND RESPONSIBILITIES: The following is a list of responsibilities related to label technician. 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 participating in internal, customer, and regulatory audits at the discretion of senior management.
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.
EDUCATION and/or EXPERIENCE:
Associates or Bachelors 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
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