Summary
- Execute assembly instructions per Batch Record requirements for Packaging and Labeling processes in compliance with cGMP guidelines.
- This will require on-time and neat documentation during the execution to assure compliance.
- Provide support to the Manufacturing Group, QA, Warehouse, and Facility operations by complying with company and FDA cGMP requirements.
- Responsible for the performance of cleaning of Primary and Secondary Packaging rooms and Packaging equipment.
- This will include the corresponding Room Sanitizations per department procedures.
Key Accountabilities
- Follow batch record instructions in the execution of the manual process for Primary and Secondary Packaging as applicable.
- Operates and tends a machine that performs one or more packaging functions, such as filling, marking, labeling, tying, packing, or wrapping containers.
- Execute assembly instructions per Batch Record requirements for Packaging and labeling processes in compliance with cGMP guidelines.
- This will require on-time and neat documentation during the execution to assure compliance.
- Provide support to the Manufacturing Group, QA, Warehouse, and Facility operations by complying with company and FDA cGMP requirements.
- Responsible for the performance of cleaning of Primary and Secondary Packaging rooms and Packaging equipment.
- This will include the corresponding Room Sanitizations per department procedures.
- Assist in the operation and set-up of automated equipment in the performance of certain primary or secondary packaging operations.
- Assist in the reconciliation and movement (Chain of custody) of materials between packaging areas and the warehouse.
- Report any observations to QA, Team Lead, Equipment Specialist CPS Project Coordinator, or Manager of potential issues that could result in deviation or investigation.
- Perform Cleaning and Sanitization of Primary and Secondary Packaging rooms.
- Support the Equipment Specialist in the execution of qualification protocols for new equipment as assigned.
- Training on SOPs to remain current for job requirements, logbook entries, and GMP documentation.
- Attend applicable meetings, discussions, etc., in support of these projects to meet the Production Schedule.
- Participate in safety processes and meetings as applicable.
- Maintain a positive, professional, and confidential relationship with sponsors. Comply with all state and federal regulatory requirements and guidelines.
- Other applicable duties as assigned.
- Adhere to all defined Safety and Sustainability requirements and expectations and seek clarification whenever Safety and Sustainability requirements and expectations are either unknown or unclear
- Promptly report identified Safety and Sustainability issues, problems, deficiencies, errors, incidents, and/or opportunities to management and correct where possible
- Stop work where deemed necessary to maintain safety.
Required Skills
- Minimum 1 to 3 years of experience operating and tending machine that performs one or more packaging functions, such as filling, marking, labeling, tying, packing, or wrapping containers.
- Must have experience in the pharmaceutical background
Job Types: Full-time, Contract
Ability to Relocate:
- Tampa, FL 33634: Relocate before starting work (Required)
Work Location: In person
