Lead, Production Operator

Role Overview

The Production Lead Operator is responsible for meeting production volume and quality targets 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

• Leads and demonstrates all activities of shift personnel on the manufacturing/production floor.
• Collaborates and coordinates with shift Production Supervisor to plan production schedules and 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 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.
• Troubleshoots, sets up, and runs processing equipment as required.
• Works closely with maintenance establishing preventative maintenance practices.
• Ensures the proper operation of equipment 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 applicable questions from operators, trains the operator on a job-by-job basis on 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, and 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 compiles and files.
• Inventories and orders production supplies as requested.
• Performs 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 125/30 cu. ft.; Rapid Mixer Granulator: 100L & 600L; 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

• 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, including inspection for quality during operation and performing all required sampling and testing.

People

• Fosters a collaborative environment in which diverse backgrounds are respected and valued.
• Establishes and maintains effective relationships with peers, team, and senior managers to communicate effectively.
• Provides clear direction and expectations for direct reports and assures that tasks and 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.
• Develops 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 creates corrective action plans where appropriate.
• Assists with personnel decisions including hiring, terminations, attendance management, wage decisions, transfers, and promotions.
• Interprets and explains the policies of the USPL Handbook so employees can understand the application of each policy as well as management's purpose for each policy.
• Applies all company policies fairly and consistently across departments and develops a relationship of trust and transparency with their employees.
• Identifies 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 Education

• Minimum of Five (5) years' work experience in nutritional, supplement, 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 & Abilities

• 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 Requirements

• 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

Work is regularly performed inside a manufacturing environment where temperatures can be moderate, with exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents.

Pay & Schedule

• 3rd shift - 11:00 PM to 7:15 AM
• Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment.

Benefits

• Health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance.
• Matched 401(k) savings plan.
• Premium pay such as overtime, shift differential, holiday pay, sick time, etc.