Plans and ensures the shift goals for training, documentation, safety, quality, and productivity for the assigned shift are met. The Lead Operator candidate must exemplify leadership potential, qualities, and decision-making skills to communicate and lead shift associates.
ESSENTIAL DUTIES AND RESPONSIBILITIES : Performs tactical planning to make decisions based on encapsulation schedule, staffing, product mix, and manufacturing priorities in order to meet high Quality, high Productivity, and On Time Delivery dates.
- Checks encapsulation schedule daily in order to plan for effective execution of activities.
- Assigns associates to work stations to meet production requirements.
- Checks log books in each room for proper completion and accuracy.
- Verifies that no foreign capsules are remaining in any room following a changeover and that all equipment is clean and the documentation is complete and accurate.
- Notifies supervisor of any problems, including poor quality, compliance risks, data integrity concerns etc.
- Collects data for shift production and inputs information into computer
- Verifies, inputs and corrects information in SAP
- Reviews Batch Production Records (BPRs) accurately and thoroughly, with Right First Pass metrics in mind. Submits detailed review of completed BPR paperwork to In Process Quality Assurance (IPQA).
- Investigates and writes events and CAPAs in Trackwise, must be able to efficiently and effectively write and obtain approval of GMP notes and memos as needed.
- Coordinates and/or supplies materials (towels, paper work, etc.) to the encapsulation rooms to minimize down time.
- Verifies the product quality of in process batches multiple times throughout their shift. Quality checks include review of fill weight statistics, seam thickness values, and physical capsule attributes.
- Conducts periodic checks throughout shift of all fill weight scales, seam microscopes, and all associated equipment for proper set-up and operation.
- Meets with supervisor to receive instructions and to exchange production information. Provides back-up for supervisor in his/her absence.
- Conducts detailed Training sessions for workers in equipment operation and when SOPs have been revised.
- May perform duties of absent associates in order to maintain production standards and goals.
- May perform other reasonable, related business duties as assigned.
- Perform periodic GEMBA walks of the encapsulation area in order to identify opportunities for improvement and GMP compliance.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Additionally, an individual must uphold the standards of conduct of the company, which include confidentiality, cooperation, and respect for people and property. Previous Project or Team leadership experience/responsibilities preferred. The 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.
EDUCATION AND EXPERIENCE:
High School diploma or GED, and two years of production experience, preferably in Encapsulation, or equivalent combination of education and experience.
LANGUAGE SKILLS: Must have excellent verbal and written communication skills to lead shift huddles, meetings, and discuss/correct issues with shift associates. Ability to read and comprehend instructions, correspondence, and memos. Ability to write correspondence. Ability to effectively present information, and to respond to questions in one-on-one and small group situations with internal and external customers/clients, and other employees of the organization, including managers. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
REASONING ABILITY: Must have the ability to solve day-to-day problems with shift staffing, equipment, products, production schedule, and documentation. Must plan, assign, and monitor daily work assignments for associates in the department based on daily shift staffing and the production schedule. Must be able to make appropriate adjustments and decisions to the work assignments throughout shift, based on productivity or change in strategy, to insure products are completed to meet customer On Time Delivery. Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
OTHER SKILLS AND ABILITIES: Ability to lead the assigned shift in the absence of a shift supervisor and make rational decisions based on leadership. Ability to use simple hand tools. Ability to use a computer.
While performing the essential duties of this job, the employee is occasionally required to sit, climb, balance, stoop, kneel, or crouch. The employee is frequently required to use hands to finger, feel, or handle and talk/hear/listen (communicate with others). The employee is regularly required to stand, walk, and reach with hands and arms. The employee must frequently push/pull/lift/carry up to 50 pounds and regularly up to 10 pounds. Close and color vision are required. It is also required that the incumbent receive a periodic eye examination which documents the level of visual acuity and color discrimination needed.