Packaging Operator III

Pegasus Laboratories•Pensacola, FL

5d•Onsite

About The Position

This position is an advanced-level packaging role responsible for supporting and executing packaging operations while maintaining compliance with all quality standards, cGMP requirements, and applicable Standard Operating Procedures (SOPs). The Packager III serves as a Subject Matter Expert (SME) for packaging processes and equipment, providing technical support, troubleshooting, and training to Operators I and II. This role operates independently and partners with Production Leads and Supervisors to ensure efficient, compliant, and high-quality packaging operations.

Requirements

High School Diploma or equivalent
Minimum 3 years of experience in an FDA/cGMP regulated manufacturing or packaging environment.
Demonstrated proficiency in packaging equipment setup, operations and troubleshooting.
Facility Core, Production Core and Packager SOP requirements.
Ability to work independently with minimal supervision.
Strong troubleshooting and problem-solving skills.
Ability to train and mentor team members.
Ability to understand and follow detailed written instructions and procedures.
Ability to perform basic mathematical calculations.
Commitment to personal and team safety.
Flexibility to support changing business needs in a fast-paced manufacturing environment.
Effective verbal and written communication skills.
Ability to analyze problems and recommend solutions.
Standing/walking (on feet) 100%
Lifting up to 25 lbs. 25%
Stooping/bending over 25%
Frequent standing, repetitive manual dexterity, reaching, walking, squatting, crawling, and safely lifting or team-lifting materials as necessary.

Responsibilities

Ensure personnel follow cGMP requirements and SOPs during packaging operations and maintain the suite is in a state of compliance.
Perform and verify equipment and room setup activities, ensuring proper documentation is completed in applicable logbooks.
Review completed batch records for accuracy, completeness, and compliance requirements.
Verify all packaging materials are released and staged, and the quantities are verified by QA on the Work Instruction Sheet.
Verify room status and packaging equipment used in the batch process are signed off by QA before starting batch.
Accurately complete all required cGMP documentation and support documentation investigations when discrepancies occur.
Operate, set up, adjust, and troubleshoot packaging equipment including labelers, heat sealers, tape machines, tablet counters, semi-automatic filling equipment, and related production equipment.
Contact Production Lead or Supervisor/Management if there are any deviations from batch records or procedures.
Ensure all approved Personal Protective Equipment (PPE) is utilized in accordance with policies and procedures.
Comprehend and adhere to all Health and Safety regulations, policies, and procedures.
Execute job duties with a high degree of quality, accuracy, efficiency, and customer service while meeting manufacturing schedules.
Share technical knowledge and provide guidance to team members to improve operational efficiency and compliance.
Train and mentor Operators I and II on equipment operation, safety procedures, and best practices.
Perform additional duties assigned to support business objectives.
Follow all company safety policies and procedures.
Participate in required safety training.
Report unsafe conditions, near misses, and incidents promptly.