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