Label Room Technician - 2nd shift
SUMMARY
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:
An Associate’s or Bachelor’s degree with (1) year of related experience is preferred. A High School Diploma with (4) years related experience and/or training is required in lieu of a degree. 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 software and label printers (Zebra).
MATHEMATICAL SKILLS:
The ability to apply moderately complex mathematical operations to assigned tasks is required; this includes 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:
The ability to respond to quality labeling inquiries from customers, supervisors or peers is required. Communication includes but is not limited to the following:
- Internal – Daily contact with Quality, Operations, Account Planners, Validation and Project Management departments related to master label creation, label printing, label approval / scanning and packaging record generation.
- External - Infrequent contact with customer representatives related to labeling practices.
REASONING ABILITY:
The ability to make rational decisions pertaining to quality compliance is required. The ability to resolve problems effectively and efficiently is required.
COMPUTER SKILLS:
Working knowledge of basic Windows applications including Lotus Notes (e-mail) and Microsoft Office programs is required. Proficiency with inventory management software (QAD, SAP), Microsoft Access and label generation software (EasyLabel) is required. Access and advanced Excel experience preferred.
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 accommodations 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 accommodations 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.
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