Compounder/Sanitizer 1st Shift (7:00am - 3:30pm)

Manufacture all the Coloplast Skin Care products.  Clean, sanitize and operate Skin Care compounding equipment and complete necessary paperwork and inspections per cGMP requirements to fulfill customer expectations.

This position controls variable cost by accurately weighing and compounding product and cleaning/sanitizing equipment per work instructions.

Major Areas of Accountability:

• Clean and sanitize equipment used in the process of Manufacturing and Packaging productions per the guidelines prescribed in the GMP’s.
• Complete cleaning and sanitization documentation as required by Coloplast procedures.
• Ensure all manufacturing equipment are cleaned and sanitized as needed prior to use.  Complete cleaning and sanitization as needed to complete scheduled jobs.
• Accurately weigh and compound product per work instructions.                                          
• Capable of setting up, operating and adjusting for all the equipment in the Compounding Area.     
• Understand, follow, and accurately complete process documentation.                               
• Compliance to cGMPs and ISO standards.
• Use of One World inventory system and MIP to accurately issue raw materials and receive the compounded product.
• Complete different quality inspections necessary for production and assure that all documentation is correctly filled out.
• Gather, stage and organize raw materials needed for the daily production runs.
• Perform preventative maintenance on the equipment as required
• Operate and package in all cells of Coloplast as needed.                                                       
• Apply continuous improvement approach to compounding function.  
• Ensure timely and proper movement of the compounded product to the Packaging Department.
• Ensure that the working environment is neat and orderly
• Follow all FDA regulations and cGMP guidelines, including the filling out of all necessary documents to ensure compliance—such as cleaning logs
• Knowledge of company policies, procedures, health and safety regulations, plans and interdepartmental relationships
• Setup of skin care to prepare materials for production line
• Clean and sanitize skin care manufacturing equipment, as required
• Ability to maintain a good working relationship with coworkers and staff
• Perform related duties as requested.

Environmental, Health and Safety Responsibilities:

This position will support Coloplast Manufacturing EHS Goals and Objectives:

• Comply with company standards for environment, health, and safety.

• Work in a safe and efficient manner in accordance with instructions from EHS and Supervisor/Lead.
• Immediately report unsafe conditions or job hazards to your Supervisor.
• Always wear required Personal Protective Equipment.
• Always follow warning signs and labels, e.g., “HOT”,”DANGER”, etc.
• Report accidents, injuries, illnesses, near misses and property damage to your Supervisor.

Essential Qualifications:

• High school diploma or GED
• ERP experience with ERP systems (Enterprise One preferred)
• Must lead by example and demonstrate professionalism
• Must set and follow through with behavioral expectations
• Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.

Relationships and Contacts:

• Other production personnel during the manufacturing process.
• Production Supervisor – receiving direction and feedback on the daily production process.
• Quality Group – daily testing and resolving any quality related issues.

• Engineering Group – resolving any machine related issues that cannot be handled by the immediate Production Group.
• Production Manager – feedback and direction of the Department and individual performance.
• Materials Group – raw material receiving and movement issues.
• Research and Development Department in compounding pilot batches.
• Set-up Personnel - to ensure timely and proper movement of the compounded product to the Packaging Department.

Required Knowledge, Skills and Abilities:

• Have job skills to learn company policies and procedures to complete tasks.
• Attention to detail and the ability to follow up on previous work
• Must work well independently and be adaptable/flexible
• Excellent verbal and written English communication skills
• Listening—practices attentive and active listening; has the patience to hear people out; can accurately restate the opinions of others even when he/she disagrees
• Able to prepare and set up workstations.
• Able to lift minimum 25 pounds on a regular basis.
• Must be able to lift 50 pounds periodically
• Must be able to stand, kneel or squat for extended periods of time
• Must be able to climb ladders, work at elevated heights, and can enter confined spaces
• Must be able to push/pull over 50 pounds
• Must be able to reach over shoulder level
• Must be able to operate power/hand tools
• Ability to organize efficiently and effectively
• Ability to convey a positive and professional image to internal and external customers
• Ability to meet critical deadlines.
• Perform various cleaning and organizing duties as required.
• Maintain records and complete necessary paperwork.
• Operate all manufacturing equipment efficiently and follow safely standards.
• Access workplace information such as the cleaning schedule to identify cleaning requirements.
• Use personal protective clothing and or equipment.
• Responsible for other duties as needed.