What are the responsibilities and job description for the Label Coordinator position at Sharp Clinical Services?
Essential Duties and Responsibilities
➢ Assist Project Management team with the labeling requirements for a particular project by interacting with vendors and business partners.
➢ Ensure label contents are configured appropriately for the specific country, intended use, and blinding as necessary.
➢ Assist Project Management team with the labeling requirements for a particular 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.
➢ Communicates with Project Management and Production to establish and maintain project timelines.
➢ Request creation of Material Masters via Smartsheets.
➢ Based off 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 support set-up 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.
➢ Work with outside vendors as necessary for procuring printed labels and labeling.
➢ Assist other Sharp Clinical Services sites with procuring labels and labeling.
➢ Communicates with Project Management and Production to establish and maintain project timelines.
➢ Request creation of Material Masters via Smartsheets.
➢ Based off 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 support set-up 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
To perform this job successfully, an individual must be able to perform each essential duty. The minimum 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.
➢ 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.
To perform this job successfully, an individual must be able to perform each essential duty. The minimum 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.
➢ 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.
