ESSENTIAL DUTIES AND RESPONSIBILITIES- Supervise and oversee manufacturing activities in Label Operations.
- Mentor and develop Label Technicians by establishing and implementing performance measures that meet internal and external customer demands.
- Responsible for providing ongoing performance feedback to Label Technicians as well as formal performance reviews.
- Make recommendations regarding employment decisions of Label Technicians (compensation, promotions, hiring, firing)
- Monitor training requirements and development of Label Technicians.
- Develop a high performing Label Operations team, ensuring collaboration and teamwork.
- Monitor Production schedule to ensure labels are delivered on time according to customer timelines and for packaging and labeling production activities.
- Plan and manage the prioritization of labeling projects accordingly to meet monthly revenue commitments.
- Oversee general expenses for Label Room and support the development of and maintenance of Key performance Indicators and operating metrics.
- Assist with conducting Quality Event investigations as a result of customer complaints, unplanned deviations and discrepancies associated with the label manufacturing operations.
- Collaborate with Senior Manager, Label Operation to review and write company SOPs relating to the Label manufacturing operations.
- Maintain, enforce, and adhere to company policies to ensure a secure and safe environment for all personnel and facility.
- Support the Senior Manager, Label Operations, in the development and implementation of new label technology and upgrade initiatives.
- Participate in Validation activities for Label Computer Systems and hardware (printers).
- Support the Senior Manager, Label Operations in vendor management activities.
- Promote communication among the team by leading regular staff meetings.
- Suggest alternative methods and procedures in solving problems and meeting changing market and production opportunities.
- Collaborate with Label Design and Coordination group on label design solutions regarding manufacturing of the labels.
- Maintain Label Operations documentation in accordance with Documentation Retention Policy.
- Oversee all the processes in Label Room (printing, inspection, receiving, staging and issue of labels, and inventory).
- Maintain Label Room in a neat and orderly fashion.
- Assist with maintaining security of Label Control area.
- Meet established schedules in a timely manner.
- Notify management of any scheduling issues and participate in developing solutions to resolve issues.
- Communicate and participate actively in team meetings.
- Maintain 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.
QUALIFICATIONSTo 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.
- High School Diploma required.
- 2-3 years prior experience in a label production or clinical packaging and understanding of Job Protocol.
- Demonstrated ability to work independently, handle multiple tasks simultaneously and meet critical timelines.
- Excellent oral and written communication is required to communicate with the team, peers, management and external contacts.
- Proficient in interpretation and implementation of cGMPs, FDA & DEA Regulations and CFRs.
- Strong leadership skills.
- Strong knowledge of computers and software including Microsoft Office products such as Word, Project, PowerPoint and Excel.