Lead, Production Operator

Job Description

Job Description

Job Description

Date

7/2022

Location

1300 Airport Rd, North Brunswick

Title

Lead, Production Operator

Department

Manufacturing 

Reports to

Manager, Production

FLSA (Exempt or Non-Exempt

Non-Exempt

Role Overview

The Production Lead (will be the Go-To person) Operator is  responsible for meeting production volume and quality targets the standards through 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 and 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/manger 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 

1. Double cone / V- blenders: 6cu. ft. to 150 125 30 cu. ft. 
2. Rapid Mixer Granulator: 100L & 600L and planetary mixer

1. Vector Fluid Bed Dryer / Processor 

1. Tray Drying Ovens 

1. K-Tron powder feeder
2. Air Classifying Mill

1. Fitz mill/Multi mill 

Compression and Encapsulation

1. Korch 55 station 53 
2. Cadmac 31’ 37’ & 45’ station (mono and bilayer) 
3. ACJ Pam
4. Syntagon

Coater  

1. Accela Coater – 48” & 60”

1. Coating medium/solution preparation

Quality 

• Participate in any investigation for a deviation involving a batch record.
• Maintain proper gowning and hygiene to ensure integrity of the product as per cGMP’s and company policies.
• Follow 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 accurate completion of Production functions.
• Learns and understands specific manufacturing operations sufficiently and is able to provide support in other areas as needed.
• Evaluates performance of employees and creating corrective action plans where appropriate
• Assists with personnel decisions including hiring, terminations, attendance management, wage decisions, transfers, and promotions. 

• Interpret and explain the policies of the USPL Handbook so employees can understand the application of each policy as well as management’s purpose for each policy.
• Apply all company policies fairly and consistently across departments and develop a relationship of trust and transparency with their employees.

• Identify strengths and weaknesses of all associates on their team to ensure optimal performance; knows which employees they can assign additional tasks to, and which need closer scrutiny

Safety 

• Responsible for ensuring each employee works in a safe and responsible manner in order to create an injury-free and incident-free workplace. Complies with all job-related safety and other training requirements.
• Keeps management informed of area activities and of any significant problems.
• Works extended hours and occasional weekend overtime.
• Other duties as assigned.

Requirements/Preferred