Production Operator

Position Summary

The Production Operator is responsible for performing various tasks on the production line and handling materials in a manufacturing environment. This role ensures that production standards are achieved through manual operations and/or operating equipment requiring average mechanical skills. The Production Operator must comply with safety standards, follow company policies and procedures, and document work accurately in batch records, logbooks, and other official documents.

Essential Duties & Responsibilities

• Production Line Operations:
• Inspect components, materials, documents, and final products during the production process or off-line.
• Perform activities as specified in batch records and Standard Operating Procedures (SOPs).
• Sample and evaluate products according to defined methods and notify supervisors if products fall outside acceptable limits.
• Perform lot changes, line clearances, and production process cleaning operations.
• Identify and segregate non-conforming products (rejects) and ensure proper handling.
• Achieve established labor standards for assigned tasks.
• Coordinate activities with team members to solve problems and optimize production efficiency.
• Compliance and Documentation:
• Document all production activities accurately in batch records, logbooks, and other required documents.
• Adhere to current Good Manufacturing Practices (cGMP), SOPs, and plant policies.
• Participate in area improvements, cost reductions, and meetings to provide feedback on process and product issues.
• Process Improvement and Troubleshooting:
• Evaluate process, product, and equipment performance based on prescribed procedures.
• Provide feedback and suggestions to improve quality, compliance, customer service, and safety within the team environment.
• Troubleshoot equipment issues, perform minor mechanical adjustments, and clear equipment jams.
• Physical Requirements and Teamwork:
• Perform various physical tasks such as lifting materials (up to 35 lbs. unassisted, up to 75 lbs. assisted).
• Ability to work in varying levels of physical activity based on the assignment.
• Work with team members to reach consensus and ensure quality standards are met.
  
  

Knowledge & Skills

Communication and Documentation:

• Ability to read, write, and communicate in English.
• Must follow both verbal and written instructions accurately.
• Ability to perform and document basic mathematical calculations (addition, subtraction, multiplication, division, working with fractions, decimals, and percentages).
• Mechanical and Troubleshooting Skills:
• Ability to perform minor mechanical adjustments and troubleshoot equipment.
• Evaluate product quality within specified limits and make adjustments when necessary.
• Compliance and Safety:
• Must be able to pass the GMP test and obtain area certifications.
• Adhere to safety procedures and wear the required personal protective equipment (PPE) including hearing protection, safety shoes, and prescription glasses (if prescribed).
  
  

Education

Minimum Qualifications, Education & Experience:

• High School diploma or equivalent required.
  
  

Experience

• Must be at least 18 years of age.
• No prior experience required, but previous manufacturing or production experience is preferred.
  
  

Physical Requirements

• Must be able to lift up to 35 lbs. unassisted and up to 75 lbs. assisted.
• Must be comfortable working in an environment that may involve outdoor work and exposure to various elements for material disposition.
  
  

Travel

• Travel is typically less than 5% of the time.
  
  

Education: High School

Skills: cgmp manufacturing,manufacturing,line production