Packaging Operator III

Job Title: Production Line Operator

Location: Tampa, FL

Pay Rate: $20/hr. on W2

Job Summary

Manage production lines to meet the established production schedule in accordance with Standard Operating Procedures (SOPs) and Good Manufacturing Principles (GMPs) while ensuring product quality standards are consistently maintained.

Job Responsibilities

Production & Operations

• Operate high-speed equipment for manual or automated assembly, filling, packaging, and labeling of pharmaceutical products, ensuring adherence to specifications.
• Conduct line setups, in-process checks, data entry, and other computer-related tasks.
• Complete batch records accurately and document production volumes per SOPs and cGMPs.
• Perform line clearances and changeovers according to SOPs and cGMPs.
• Conduct in-process inspections and reconcile components and finished products to ensure accuracy and accountability.
• Clean packaging rooms and machinery in compliance with SOPs and GMP requirements.
• Accept or reject products based on established cGMP and customer requirements.
  
  

Safety & Compliance

• Comply with all safety regulations and conduct activities in a safe, efficient manner.
• Apply 5S and cGMP principles in all work areas.
• Ensure adherence to ethics, EHS, financial, HR, and general business policies.
• Maintain compliance with FDA, ISO 13485, EC, CMDR, OSHA, EPA, DOT, and other relevant regulatory standards.
• Participate in environmental, health, and safety programs to promote safe operations.
  
  

Documentation & Quality

• Complete required documentation (batch records, logbooks, etc.) accurately, legibly, and in a timely manner.
• Verify and document correct component usage.
• Ensure products meet all specifications related to packaging, labeling, and lot number identification.
• Maintain a clean, organized work area to ensure cGMP compliance and good housekeeping.
  
  

Teamwork & Continuous Improvement

• Participate in team meetings, training sessions, and problem-solving discussions.
• Provide input to improve work processes and assist with SOP revisions.
• Train and support less experienced team members when required.
  
  

Principal Accountabilities

Packaging Department:

• 50%: Operate and monitor packaging equipment, perform changeovers, ensure materials availability, and maintain product quality and efficiency.
• 30%: Complete documentation accurately and verify component and product specifications.
• 20%: Participate in meetings, training, and continuous improvement activities; assist and train others as needed.
  
  

Education & Experience Requirements

• Education: High School Diploma or equivalent required.
• Experience: Minimum 1 year of related work experience, preferably in a high-speed production or GMP manufacturing environment.
• Regulatory: Experience in GMP-regulated or aseptic production environments preferred.
• Technical Skills:
• Basic Microsoft Office proficiency; SAP experience preferred.
• Understanding of SOPs, cGMPs, and quality documentation.
  

Knowledge, Skills & Abilities

• Strong attention to detail and self-motivation.
• Excellent hand-eye coordination and manual dexterity.
• Basic math skills (addition, subtraction, multiplication, division).
• Ability to read, comprehend, and communicate effectively in English.
• Professional team communication and adherence to instructions.
• Basic computer proficiency (Windows-based systems).
• Willingness to work flexible shifts (up to 12 hours) based on business needs.
• Ability to stand and walk continuously; lift up to 40 lbs (men) / 35 lbs (women).
• Ability to bend, climb, squat, and stretch as needed.
• Must comply with gowning and cleanroom requirements (hairnets, beard covers, safety shoes, goggles, etc.).
• Proficient in operating, cleaning, and maintaining production equipment and tools properly.
  
  

Regulated Responsibilities

The incumbent must ensure full compliance with:

• GMP and EHS standards.
• FDA, ISO 13485, EC, MDD, CMDR, OSHA, EPA, DOT, EEOC, ADA and other applicable regulations.
• Company policies to enhance the welfare of customers, employees, and the community.