Line Leader 1st Shift

Manufacturing Line Lead II

Under the direction of a Manufacturing Supervisor, this role assists in directing employees' activities within an assigned manufacturing room/rooms or areas to meet the daily production schedule. Takes complete responsibility for the product quality, resource utilization, operational efficiency, and employee safety within the assigned packaging room/rooms or area. Assist supervisor to ensure that all processes are utilized, and products packaged conform to customer and Company standards and specifications.

Assist the Production Supervisor in supervising daily operations for the organization and act as a liaison between the supervisor and other staff, ensuring that procedures are followed, while also suggesting ideas for streamlining processes.

Develop a productive, profitable and achievement-oriented working environment for employees. May be assigned to a line/area as a production person. Other duties may be assigned.

Communicates supervisor's job orders to employees. Ensure all batch record entries are performed. Maintain line/area in an orderly and safe manner while maintaining GMPs. Notify supervisor with personnel issues. Observe packaging operations for optimum performance. Assist supervision with reporting the production performance metrics. Suggest changes in working conditions and use of equipment to increase efficiency of work crew. Responsible for training the designated peers as a replacement. This is completed at management's request. Complete room line/area changeovers including but not limited to startups and lot changes. Assist Supervisors by assigning associates to complete line/area cleans and perform clean checks as needed. Perform attendance checks at the beginning of shift for proper headcount. Help provide and sustain training as needed. Communicate with support staff for priority set-ups and/or start-ups. Verify the completion of dailies and challenges for ongoing rooms. Provide status of lines/areas to Management as needed and ensure that scheduled lines/areas are ready, or backups are available. Ensure that associates complete their Batch Record Review corrections prior to the end of their shift; complete corrections for employees if necessary. Ensure that pending corrections do not exceed 48 hours. Ensure that any controlled bulk is staged and is properly monitored if needed for the beginning of the next shift. Recommend measures to improve production methods, equipment performance, and quality of product. Analyzes and resolves work problems or assists workers in solving work problems. Assist with Deviations and/or Investigations when required. Other duties may be assigned.

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 accommodation may be made to enable individuals with disabilities to perform the essential functions.

Responsible for notifying production supervisors of performance, policy and personnel issues.

Preferred 4-year BS, BA or BT degree in a technical discipline or 2-year associate's degree with 3 to 5 years pharmaceutical packaging experience or an equivalent training and/or experience. Experience in inspection of pharmaceutical or related industry is required. Good documentation and communication skills. Good organizational and planning skills. Proficiency in MS Office (MS Excel, and MS Word, in particular). Previous Leadership experience (conflict resolution, critical thinking, communication, etc.) is required.

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 accommodation 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 talk or hear. The employee frequently is required to stand, walk; sit; use hands to finger, handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, and ability to adjust focus.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently exposed to moving mechanical parts. The noise level in the work environment is usually moderate.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.