Packaging Operator 1

Packaging Operator 1

JOB SUMMARY:

Packaging Operators are operators that have been qualified on specific operations and specific Packaging Lines at Aveva Tamarac DDS. The position requires familiarization with the underlying engineering and scientific principles on which Packaging and Labeling processes are based.

Level I Packaging Operators are responsible for specific operations and Packaging Line equipment on which they are trained and qualified. These responsibilities include achieving and maintaining qualifications for Packaging and Labeling operations and may also include setting up adjusting and equipment and area cleaning. Level I Packaging Operators routinely perform pre-and post-operational checks, operate Packaging and Labeling equipment for production, perform cleaning of equipment and areas, and document work performed per SOPs and Batch Documentation requirements.

Level I Packaging Operators may be assigned to specific tasks within the following general range of duties and responsibilities based on the specific training and qualifications they have achieved. Training of Level I Packaging Operators is performed to qualify each operator in all of the specific duties and responsibilities applicable to each Packaging Line, on a line-by-line basis. Following this strategy, Operators become fully qualified for every Operator's responsibility on individual lines, and may successively be trained on operating every line.

• Packaging Operators follow Batch Record instructions that specify materials, components, labeling, and processing parameters to be utilized, in-process sampling, testing, and inspection, etc. Packaging Operators document the work performed as specified in the Batch Record.
• During packaging operations, Packaging Operators are responsible for monitoring the operation of the equipment, the processing parameters utilized, and the product produced.
• Based on inspection and monitoring activities and feedback from downstream manufacturing staff and On-Line QC, the Packaging Operator makes adjustments as required or specified in Batch Records, performs clearance of machine jams, troubleshoots minor production problems, and makes minor adjustments for processing parameters, etc.
• After each run, the Packaging Operator shuts down the line or prepares for lot change as directed in Batch Records and required by the Production Schedule.
• Packaging Operators perform product counts, initiate Line Clearance and/or Cleaning Procedures, confirm satisfactory completion and recording of line clearances, equipment and area cleaning, post status and in-process product/lot number labeling, and complete all associated documentation as specified in Batch Records and SOPs.
• Packaging Operators maintain Packaging Lines in a clean and orderly state. Performs minor and spot cleaning as required.
• Provides QA Support for Audits and Inspections.
• Verifies documentation and reports for accuracy.
• Comply with all aspects of quality management systems, cGMP policies, documentation, and record-keeping per industry and FDA standards. Enforces safety and sanitation regulations.

Qualifications

The individual must possess the following knowledge, skills and abilities and be able to explain and demonstrate that he or she can perform the essential functions of the job, with or without reasonable accommodation, using some other combination of knowledge, skills, and abilities:

• Must have legible handwriting, and the ability to perform accurate documentation.
• Must be able to count accurately, and have good basic math skills such as adding, subtracting, multiplying, and dividing.
• Must be organized, capable of following instructions, and have the ability to ability to coordinate multiple activities simultaneously.
• Must be able to work in a methodical and organized fashion and maintain mental focus to ensure efficient and accurate completion of individual tasks.
• Must be mechanically oriented and understand the function and operation of common tools and the operation of PLCs and graphical user interfaces on equipment.
• Must be familiar with functions of equipment systems that operate utilizing multiple utilities such as compressed air, electrical supply, vacuum, steam, chilled water, etc.
• Must have basic computer skills including data entry.

Education:

Associate Degree or High School Diploma or equivalent as well as good handwriting and basic data entry and mathematical skills.

Experience:

Two years of experience in Food/OTC or other FDA Regulated production environments preferred.

Salary : $22 - $26