Lead, Production Operator

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

Education & Qualification

• Minimum of Five (5) years’ work experience in nutritional’s, supplements, food, or pharmaceutical manufacturing industries.
• Hands on experience with any of the following processes: Blending/Granulation, Tablet Compression and/or Film Coating, Encapsulation, or Pharmacy/Pre-Weigh Dispensing

Skills & Ability

• Demonstrates ability to work in a team and assist others.
• Able to follow written instructions precisely and perform basic math calculations as required.
• Understands and is knowledgeable of cGMP, OSHA standards etc.
• Mechanically inclined to understand the inner workings of equipment.
• Demonstrates the ability to read and write basic English in order to be able to understand the industry regulated instruction sheets.

Physical Requirement

• Ability to lift up to 35 lbs.; occasionally lift and move up to 50 pounds.
• Must stand and walk on production floor a minimum of 6 hours per shift.
• Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from waist, or squatting, walking short distances.
• Occasionally works from a rolling ladder or step stool.
• Must be able to wear all PPE including lab coat, face mask, booties, gloves, safety glasses/goggles and respirators.

Work Environment (Office, Warehouse, temperature extremes, etc.)

USPL is proud to be an Equal Opportunity Employer.