Lead, Production Operator

Lead, Production Operator

Date - 7/2022 - Location - 1300 Airport Rd, North Brunswick

The Production Lead Operator will be the go-to person responsible for meeting production volume and quality targets through the safe, efficient use of resources and materials in production processes. Enters data into production control system. Safety, sanitation, housekeeping, GMP standards, problem solving ability as well as good employee relations are considered key elements to success. This position is responsible for planning, coordinating, and managing all production activities of those employees on the floor.

They will need to coordinate and partner with other departments to maintain schedules and effect necessary changes and revisions.

Areas of Responsibility

Production Leads and demonstrates all activities of shift personnel on the manufacturing/production floor. Collaborates and coordinates with shift Production Supervisor to plan production schedules, activities on the production floor to meet production and delivery targets. Ensures that production schedule is met by distributing workload in accordance with changing priorities. Communicates with the production supervisor/manager as to the beginning and end of product runs, washouts, and anticipated downtime.

Responsible for verifying paperwork is being completed as per the company standards, current Good Manufacturing Practices (cGMP's), Lot Tracking, washouts, pre-shift, and post-shift. Ensures all proper line clearances and set-up performances. Trouble shoot, set-up, and run processing equipment as required. Works closely with maintenance establishing preventative maintenance practices. Ensures the proper operation of equipment's by coordinating, preventative maintenance, repairs; and evaluating new equipment and techniques.

Responsible for product quality and workmanship consistent with the Company's manufacturing objectives, QMS and profit goals. Provides daily reporting of production metrics. Performs required training and guidance as needed, responds to any applicable questions from operators, trains the operator on a job-by-job basis, the fundamental production steps if required. Maintains a work environment which fosters teamwork and supports the company's efforts to continuously improve processes.

Ensures production operations are properly controlled and regulatory compliance requirements are met. Ensures the accuracy of batch documentation, Standard Operating Procedures, critical documentation templates. Ensures that all equipment is in good condition and current calibration, training is current, and high standards of housekeeping are maintained in all areas of responsibility. Evaluates and solves production problems by reviewing the area of concern, developing potential solutions, technically evaluating, or testing the solutions, and preparing recommendations for management.

Prepares production reports and variance explanations, and accurately complies and files;
Inventories and order production supplies as requested. Performs the operations like cleaning, and set-up of the following pieces of equipment as well as new equipment:
Blending and Granulation, Double cone / V- blenders, Rapid Mixer Granulator, Vector Fluid Bed Dryer / Processor, Tray Drying Ovens, K-Tron powder feeder, Air Classifying Mill, Fitz mill/Multi mill, Compression and Encapsulation, Korch 55 station 53

Cadmac 31' 37' & 45' station (mono and bilayer), ACJ Pam Syntagon Coater , Accela Coater – 48" & 60". Participates in any investigation for a deviation involving a batch record. Maintains proper gowning and hygiene to ensure integrity of the product as per cGMP's and company policies. Follows batch records, SOP's, and cGMP guidelines to ensure product specifications and tolerances are met.

Ensures full compliance with Company policies, procedures, GMP's, Ethical Business Practice, and SOP's at all times. Ensures documentation such as operation logs, batch records, etc. are fully completed, signed and in compliance with company standards and regulatory requirements. Ensures that product meets applicable quality standards. This includes inspection for quality during operation and performing all required sampling and testing.

People

Foster a collaborative environment in which diverse backgrounds are respected and valued. Establish and maintain effective relationships with your peers, team, and senior managers to communicate effectively. Provides clear direction & expectations for direct reports and assures that tasks & responsibilities are clear. Sets goals and objectives in alignment with the organization for self and direct reports:
Creates action plans, sets milestones, and delivers progress reports and developmental plans for team members. Develop employees that contribute to the daily success of the line and can be successful in the supervisor's absence. Maintains open lines of communication with employees, peers, and management. Assumes responsibility for the efficient, timely, and…