Packaging Operator

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers to deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.

Job Title: Packaging Operator III

Location: Tampa, FL, 33634

Duration: 12 Months

Job Type: Tempporary Assignment

Work Type: Onsite

Shift: Monday to Friday from 07:00 AM to 03:30 PM

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's procedures.

Responsibilities

• Follow batch record instructions in the execution of manual processes for Primary and Secondary Packaging as applicable.
• 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.
• Operate and tend machines that perform one or more packaging functions, such as filling, marking, labeling, tying, packing, or wrapping containers.

Required Skills

• 1 3 years of experience in packaging operations.
• Experience in following batch record instructions and SOPs.
• Supporting qualification protocols for new equipment.
• Experience operating or assisting with automated packaging equipment.
• Ability to perform cleaning and sanitization per procedure.
• Familiarity with cGMP guidelines and FDA compliance.
• Capable of assisting in reconciliation and movement of materials.
• Proficiency in executing job documentation and logbook entries.
• Participation in safety and sustainability processes.
• Ability to report and escalate deviations or quality concerns.
• Willingness to stop work to maintain safety when necessary.
• Ability to attend and contribute to cross-functional meetings.

TekWissen Group is an equal opportunity employer supporting workforce diversity.