Label Coordinator

Overview

Join to apply for the Label Coordinator role at Sharp Services .

Location: Bethlehem, PA. Salary ranges and posting dates are shown where applicable.

Responsibilities

• Assist Project Management team with the labeling requirements for a project by interacting with vendors and business partners.
• Ensure label contents are configured appropriately for the specific country, intended use, and blinding as necessary.
• Work with Project Management, Packaging Design and Production to identify labeling operation requirements.
• Work with outside vendors as necessary for procuring printed labels and labeling.
• Assist other Sharp Clinical Services sites with procuring labels and labeling.
• Communicate with Project Management and Production to establish and maintain project timelines.
• Request creation of Material Masters via Smartsheets.
• Based on study requirements, design all required label proofs.
• Setup study-specific labeling requirements in labeling printing software.
• Prepare paperwork for Sharp Clinical Services printed labels and labeling.
• Understand patient randomization and material list schemes.
• Provide setup support for projects requiring Scan Assembly.
• Provide backup support for the Label Room as needed.
• Upload randomizations into SAP prior to the start of Production.
• Participate in training of new Label Coordinators.
• Generate discrepancy/investigation reports as required.
• Complete requisitions for Label Room supply and equipment.
• Manage project timelines and deliverables.
• Suggest alternative methods and procedures in solving problems and meeting changing market and production opportunities.
• Communicate and participate actively in team meetings by offering alternative methods and procedures in solving problems and meeting changing market and production opportunities.
• Ensure compliance with cGMP and all competent authority guidelines by regularly reviewing and adhering to SOPs.
• Adhere to set safety standards.
• Achieve expected performance measures.
• Other duties as assigned.

Qualifications

• Bachelor’s Degree or equivalent work experience.
• Some prior experience in ordering labels and understanding Job Protocol preferred.
• Minimum of 1 year experience in the labeling area including production, preferred.
• Demonstrated ability to work independently, handle multiple tasks simultaneously and negotiate and meet critical timelines.
• Excellent oral and written communication is required to communicate with the team, peers, management, and external contacts.
• Proficient with interpreting and implementing cGMPs, FDA & DEA Regulations and CFRs.
• Strong leadership to mentor and develop team to achieve Company goals.
• Strong knowledge of Microsoft Office Products, including Word, Project and Excel.
• Preferred knowledge of SAP & SmartSheets.
• Must be able to review and produce a high volume of printed material with an extremely high level of accuracy and extremely low rate of errors.

Language Skills

Strong ability to read, write and comprehend the English language, read and interpret legal and technical documents, and write routine correspondence. Ability to communicate effectively with employees at all levels of the company. Good interpersonal skills.

Computer Skills

Proficient with Microsoft Excel and strong knowledge of ERP systems is strongly preferred, with SAP S4 HANA experience a highly desirable advantage.

Reasoning Ability

Ability to think creatively, solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to handle multiple tasks and make sound decisions.

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. While performing the duties of this job, the employee is frequently required to sit, use hands to finger, handle or feel, reach with hands and arms, and talk or hear. Employee is occasionally required to stand, walk, climb, or balance and stoop, kneel, crouch or crawl. The employee regularly lifts and/or moves up to 10 pounds, frequently up to 25 pounds and occasionally up to 50 pounds. Must be able to traverse the facility on occasion. Specific vision abilities required include close, color vision and ability to adjust focus.

Environmental Conditions

The noise level in the work environment is usually moderate.

Seniority level

• Entry level

Employment type

• Full-time

Job function

• Other

Industries

• Pharmaceutical Manufacturing

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