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Position Title:Label Designer

Reports to:Quality Ops Manager

FLSA Status:Non-Exempt

Location:Philadelphia, PA

SUMMARY:

• Design labels in accordance with site procedures and HDMA Guidelines for Bar Coding in the Pharmaceutical Supply Chain.
• Print Shipper, Pallet & Bundle Labels for the packaging operation in compliance with cGMP's and PCI standard operating procedures.
• Oversees daily schedule to assure on time deliverables of labels to production floor.

ESSENTIAL DUTIES AND RESPONSIBILITIES INCLUDE THE FOLLOWING (OTHER DUTIES MAY BE ASSIGNED BY QUALITY OPERATIONS MANAGEMENT):

• Acts as the Quality oversight for Label Room Operations.
• Acts as a contact for Project Management and the customer for the identification and interpretation of customer labeling requirements.
• Works closely with Project Management ensuring accurate timelines and label requirements.
• Design labels in the form of serialized and non-serialized & create labels using the label management system.
• Interpret the appropriate text, font, direction, label size and barcode (2D, SSCC, GTIN etc.).
• Obtain and interpret label design request documents.
• Utilize, manage and update the ERP system correlating with Label Room activities.
• Reviews and approves label room request and associated forms for accuracy.
• Remains updated on Production daily activities to ensure operational requirements are met.
• Handle, communicate and distribute label room txt. files with serialization.
• Communicate with vendor and Central Parts, managing inventory of Roll Stock labels.
• Creating miscellaneous labels utilized throughout the facility.
• Monitors the daily and weekly progress of projects issued by the department management.
• Reviews and interrupts standard operating procedures (SOP's), and facilitates training on SOP's throughout the department.
• Participates in any CAPA (Corrective Action Preventative Action) resolution pertinent to Label Room processes and procedures.
• Manages and updates label room schedule and prioritize creation of non-serialized labels.
• Performs Line Clearance purges of label room printers.
• Performs barcode challenges (LVS, RJS) producing acceptable barcode reports.
• Manage destruction and reject handling of extra labels.
• Manage, store and sort label room files.
• Monitors activities for GMP compliance.
• Maintains housekeeping duties of the label room.
• Mentors/train label technicians and designers.
• Other duties assigned by Quality Operations Management.
• Shift is 8:00am - 4:30pm Monday-Friday

Special 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. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

• Stationary Position: From 1/4 to 1/2 of the day.
• Move, Traverse: From 1/4 to 1/2 of the day.
• Operate, activate, use, prepare, inspect, or place: Up to 1/4 of the day.
• Install, place, adjust, apply, measure, use, or signal: Up to 1/4 of the day.
• Ascend/Descend or Work Atop: None.
• Position self (to) or Move (about or to): Up to 1/4 of the day.
• Communicate or exchange information: 3/4 of the day and up.
• Detect, distinguish, or determine: 3/4 of the day and up.
• On an average day, the individual can expect to move and/or transport up to 10 pounds: less than 1/4 of the day.

This position may have the following special vision requirements.

• Ability to focus
• Ability to read text of a smaller font size

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. The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.

• Work is performed in areas with moderate risk or discomfort that may require special safety precautions, such as wearing protective clothing or gear for: up to 1/4 of the day.
• Work is primarily performed at a desk and/or in an office environment: for up to 3/4 of the day.
• The noise level in the work environment is typically: Low.

Qualifications:

The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

• High School Diploma or GED and 3-6 months related experience and/or training.
• Intermediate Mathematical Skills.
• High Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.
• High Standard of Report Writing.
• Ability to follow instructions and respond to management direction.
• Ability to work independently and/or part of a team.
• Ability to display excellent time management skills.
• Ability to demonstrate attention to detail.

Preferred:

• College degree preferred in graphical design field.
• 1 (one) year label design experience in a pharmaceutical setting.
• Knowledge in EZ Label, Bartender or Prisym
• JDE and/or other ERP system management.
• 1 (one) year cGMP experience.

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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.