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About the Role

This position operates production equipment, including non-sterile filling, packaging, and labeling machines. Responsibilities include supplying materials, cleaning equipment and areas, inspecting parts, and troubleshooting basic issues.

Responsibilities

• Operates all assigned equipment appropriately and per established methods and procedures, including setup, operation, and cleaning.
• Completes and reviews area production documentation, verifying accuracy and real-time recording.
• Maintains open communication with management regarding production updates, deviations, and corrective measures.
• Exchanges work status information within the department, management, and with coworkers.
• Maintains a clean environment and work area using appropriate cleaning solutions and methods.
• Ensures designated equipment and tools are cleaned and sanitized appropriately.
• Cleans and sanitizes required glassware using a washer and completing wash documentation.
• Handles raw materials and components appropriately, including procurement, weighing, verification, dispensing, and formulating solutions.
• Maintains Aseptic Process Area sterile gowning qualifications.
• Responds to equipment alarms or malfunctions immediately by identifying conditions and communicating them to subject matter experts.
• Assists coworkers in the production of finished product according to established time limits.
• Receives and ships all plant uniforms and scrub uniforms for cleaning.
• Receives and stocks all garments and supplies for clean rooms and sterile core, and prepares garments for shipping and sterilization.
• Assists with special projects as required or requested.
• Promotes a safe and harmonious work environment.
• Maintains compliance with SOPs, GMPs, and all company policies.
• Performs other duties as assigned or required.

Requirements

• Associate or Bachelors Degree from a regionally accredited institution.
• One or more years previous work experience in a hospital or manufacturing environment or doing clean room filling preferred.
• Experience working in a production environment, ideally in a clean room setting.
• Basic mechanical skills related to operation of equipment.
• Knowledge and skill in operating various specialized equipment, such as filling, wash, and sanitizing equipment.
• Knowledge of clean room procedures, preferred but not required.
• Knowledge of and compliance with GMP (Good Manufacturing Practices) regulations, preferred but not required.
• Knowledge of general computer functions such as Microsoft Office programs, spreadsheets, etc.
• Skill in handling several projects or tasks at the same time, or within a given time frame.
• Advanced Problem Safety Sensitivity; the ability to recognize a safety issue or potential safety issue.
• Skill to use time management techniques in personal daily tasks and that of others.
• Skill in attention to detail and focus on quality, accuracy, sterility, and aseptic technique.
• Skill in communicating with coworkers, management team members, and other individuals in a courteous and professional manner.
• Skill in math with an understanding of measurements and conversions.
• Skill in recognizing deviations from procedures and anomalies, and immediately communicating.
• Ability to apply critical thinking.
• Ability to maintain confidentiality of all internal and external information and processes.
• Ability to follow personal hygiene standards/procedures according to SOP.
• Ability to wear protective attire as required and don gowning materials in correct order per SOP.
• Ability to follow all appropriate SOPs and safety procedures per company guidelines.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to be flexible in work hours.
• Ability to provide motivational support.
• Ability to maintain a professional, positive attitude at all times.
• Ability to trust, develop, maintain, and strengthen partnerships with others inside the organization who can provide information, assistance, and support.
• Ability to lead by example.
• Ability to work in a fast-paced environment.
• Ability to complete assigned tasks.
• Ability to take initiative, including asking for and offering help when needed; performs work independently without being prompted.
• Ability to prioritize and plan work activities; manages time effectively and adapts quickly to changing priorities.
• Ability to handle multiple tasks and organize resources to ensure work is completed on time and in accordance with established policies and procedures.
• Ability to maintain a positive attitude and work in a team environment.
• Must be able to read reports and use computer 75-100% of time.
• Must be able to hear well enough to communicate with coworkers 75-100% of time.
• Must be able to stand to open files and operate office equipment; mobility between departments and attend meetings of coworkers and management 75-100% of time.
• Must be able to climb, stoop, or kneel to perform routine tasks within the scope of job 50-74% of time.
• Must be able to lift up to 50 lbs./ Pulling/Pushing within the scope of job 25-49% of time.
• Must be able to write, type, and use office equipment; along with handling material and equipment 75-100% of time.

Skills

• Operating production equipment
• Non-sterile filling
• Packaging
• Labeling
• Supplying materials
• Cleaning equipment
• Cleaning production areas
• Inspecting parts
• Troubleshooting basic issues
• Assisting with training
• Set up equipment
• Operational documentation
• Tagging/palletizing/placement of items
• Reviewing production documentation
• Accurate data entry
• Real-time recording
• Communication with management
• Production updates
• Deviations
• Corrective measures
• Work status exchange
• Maintaining clean environment
• Using cleaning solutions
• Cleaning and sanitizing equipment
• Cleaning and sanitizing glassware
• Handling raw materials
• Handling components
• Procurement of raw material
• Weighing materials
• Verification of materials
• Dispensing raw material
• Formulating solutions
• Mixing dispensed materials
• Handling materials per SOPs
• Completing MRT for rejected/returned materials
• Aseptic Process Area sterile gowning
• Responding to equipment alarms
• Identifying alarm conditions
• Communicating conditions to subject matter experts
• Assisting coworkers
• Receiving uniforms
• Shipping uniforms
• Stocking garments
• Stocking supplies
• Preparing garments for sterilization
• Assisting with special projects
• Promoting safe work environment
• Promoting harmonious work environment
• SOP compliance
• GMP compliance
• Company policy compliance
• Basic mechanical skills
• Operating specialized equipment
• Clean room procedures
• Good Manufacturing Practices (GMP)
• General computer functions
• Microsoft Office programs
• Spreadsheets
• Handling multiple projects/tasks
• Time management
• Problem Safety Sensitivity
• Attention to detail
• Focus on quality
• Focus on accuracy
• Focus on sterility
• Focus on aseptic technique
• Professional communication
• Math skills
• Understanding measurements
• Understanding conversions
• Recognizing deviations
• Recognizing anomalies
• Critical thinking
• Confidentiality
• Personal hygiene standards
• Wearing protective attire
• Donning gowning materials
• Following SOPs
• Following safety procedures
• Solving practical problems
• Flexibility in work hours
• Motivational support
• Maintaining professional attitude
• Maintaining positive attitude
• Developing partnerships
• Maintaining partnerships
• Strengthening partnerships
• Leading by example
• Working in a fast-paced environment
• Completing assigned tasks
• Taking initiative
• Asking for help
• Offering help
• Working independently
• Prioritizing work activities
• Planning work activities
• Managing time effectively
• Adapting to changing priorities
• Handling multiple tasks
• Organizing resources
• Working in a team environment

Work Type

• 2nd Shift
• Monday-Thursday 4x10-hour shifts 1pm-11:30pm

Experience Level

• One or more years previous work experience in a hospital or manufacturing environment or doing clean room filling preferred
• Experience working in a production environment, ideally in a clean room setting

Education Level

• Associate or Bachelors Degree from a regionally accredited institution

Benefits

• Exceptional healthcare insurance; over 80% of premiums employer-paid
• 100% match of first 4% 401k plan and immediate vesting
• Generous time-off plan (because family is important), up to 5 weeks to start (vacay + sick + holiday)
• Many fun events throughout the year!

About the Company

• Our growth is real and we’re looking for the best of the best who are committed to making a difference. We want people who are enthusiastic, rigorous, collaborative, and confident in teams. Above all, we want people who share our fundamental core values - quality, reliability, meeting customer needs, integrity, respect for each other, and collaboration.

Equal Opportunity

• EEOC 'Know Your Rights' Poster: https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12.pdf
• Employee Rights Under the Polygraph Protection Act: https://www.dol.gov/sites/dolgov/files/WHD/legacy/files/eppac.pdf [https://www.dol.gov/sites/dolgov/files/WHD/legacy/files/eppac.pdf]