3rd shift Label Technician

Responsibilities include preparation, inspection, documentation and distribution of labels used during the packaging process.  This role requires proficiency in label creation / printing software as well as use and maintenance of label printers.  The label technician must prioritize label creation and printing activities while performing a critical, detailed review of each run.  Additionally, participation in internal, external or regulatory audits will be required at the discretion of senior management.

The scope of this position includes all Sharp facilities.  The impact of master label creation / label printing could expose the company to significant risk or economic loss.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

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

• Responsible to ensure and enforce GMP compliance (including but not limited to: gowning attire, personnel hygiene, handling/storage of materials and good documentation practices) throughout GMP facility areas.
• Responsible for preparation of internal labels associated with in-process work and component identification.
• Responsible for the preparation of finished labels associated with clinical products, pallet identification and finished products.
• Responsible for use of QAD (inventory management software) to verify lot number and expiration, if appropriate, for labels generated, and to input label printing process completion.
• Responsible for documented evaluation of labels.
• Label approvals:
• Verify printed lot number and expiration date against the work order and packaging record.
• Verify label text, formatting, size and color against the master label proof.
• Verify barcode scan as applicable.
• Complete appropriate approval documentation.
• Responsible for use of printers specific to each label printing run.
• Responsible for minor maintenance of printers used for label printing runs.
• Responsible to verify clearance of label printers between label printing runs.
• Responsible for participating in internal, customer, and regulatory audits at the discretion of senior management.
• Responsible for training peers.
• Responsible for ordering labeling supplies as required assuring functionality of the label room is not impacted.
• Responsible for packaging record generation as assigned:

• Generation of Production Packaging Records from Master Packaging Records
• Packaging record approval including AQL Sampling Plan calculation and/or verification and verification of label and pallet tag information prior to delivery to production room:

• Ensure documentation within the packaging record is accurate (lot numbers, expiry dates, item numbers, etc.) and consistent throughout.
• Ensure packaging has been updated per change control as applicable.
• Ensure Pallet Tags are prepared according to packaging record and work order specifications.
• Ensure all pages issued to the packaging record are accounted for prior to release for use.

• Responsible for review and approval of GMP documents such as MPR and BOM
• Responsible to assist Label Room coworkers and Supervision as requested.
• Responsible to write memos or conduct investigations at management’s request.

• Responsible for training of designated peers.

• Responsible for participating in continuous improvement projects.

SUPERVISORY RESPONSIBILITIES:

None

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

EDUCATION and/or EXPERIENCE:

A High School Diploma with at least 2 years of related experience and/or training is required. Experience with label generation in a pharmaceutical or related industry is preferred.

• General knowledge of FDA regulations related to cGMPs.
• General knowledge of quality control/assurance.
• Experience with inventory management software (QAD).
• Experience with label generation utilizing EasyLabel softw