Clean Room Assembler

Clean Room Assembler:
Toano, Virginia
SUMMARY:
This full-time, non-exempt position reports directly to the Production Supervisor or Production Manager, as applicable, and receives daily instructions from the immediate supervisor and/or Team Leader. This position works under direct supervision and uses written work instructions. Production Clean Room Assemblers will be trained to procedures and processes to perform all functions that are required within the clean room to produce custom procedure trays.


ESSENTIAL DUTIES AND RESPONSIBILITIES:
Include the following, other duties may be assigned.

o Assembling duties will encompass the following:
o Accurately assemble custom procedure trays by learning to identify medical components by description and vendor item number.
o Follow the assembly instructions and place the correct component and quantity (using the counting method) into the tray.
o Visually inspect components for defects; verify conformance to specifications and report and/or reject defective components, informing the team leader per guidelines.
o Complete prep assemblies within a custom procedure tray; identify the right wrap for the build and proceed to wrap the tray per customer's specified sterile technique.
o Set up duties will encompass the following (after training to the set-up procedure):
o Ensure communication occurs between the Team Leader and set-up person before the job is set-up so special instructions can be provided as needed.
o Ensure three job orders are ready for the line at all times when applicable.
o Verify contents of Device History Record to include: assembly instructions; pick ticket; kit insert labels; expiration dates of product; and special notes pertaining to particular builds and box labels.
o Make copies of assembly instructions.
o Verify vendor ID and description of all components (if applicable) when arranging them sequentially on the carts.
o Verify at least one product is batch counted on a cart. Remove outer packaging from product when necessary.
o Sealing duties (after training to the sealing procedure) will encompass the following:
o Ensure the sealing machine is properly calibrated and the temperature, speed, and pressure are at the correct settings.
o Check for the correct header bag and proper insert label.
o Seal the package to the proper specifications.
o Complete necessary paperwork.
o Assumes additional responsibilities as requested by immediate supervisor, other management personnel or as business needs dictate.
* Supervisory Responsibilities:
o This job has no supervisory responsibilities.

COMPENTENCIES:
To perform the job successfully, an individual should demonstrate the following competencies:

o Teamwork - Puts success of team above own interests; gives and welcomes feedback; contributes to building a positive team spirit; Supports everyone's efforts to succeed; Exhibits objectivity and openness to others' views.
o Quality - Applies feedback to improve performance; Monitors own work to ensure quality.
o Quantity - Meets productivity standards; Works quickly; Completes work in timely manner.
o Safety and Security - Observes safety and security procedures; Reports potentially unsafe conditions.
o Communication ¿ Listens and gets clarification; responds well to questions; demonstrates group presentation skills; participates in meetings.

QUALIFICATIONS:
?To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


Education and/or Experience
o High school diploma or GED preferred.
o 3-6 months packaging/boxing experience in a production / warehouse environment preferred.
* Language Skills
o Must be able to comprehend English words and directions required for workplace safety and associated with business procedures and practices.
* Reasoning Ability
o Requires an ability to handle multiple tasks; prioritize work with guidance from immediate supervisor or team leader.
* Computer Skills
o Must possess the willingness to learn and receive limited computer training when appropriate in the training cycle.

Other Qualifications
o Ability to perform tasks accurately and efficiently with excellent attention-to-detail is a must.
o Excellent eye-hand coordination is required.
o Manual dexterity is required.
o Demonstrate adaptability to a changing work environment and varying daily tasks.
o Must possess the ability to follow procedures and maintain a professional attitude in difficult situations.
o Must possess the ability to work well as a team member.
o Requires proven ability to work under direct supervision, follow instructions and pre-established guidelines to perform the functions of the job.
o Requires an excellent attendance record.
o Ability to support fiscal year inventory process.

PHYSICAL DEMANDS:
o Must be able to walk or stand 100% of the shift.
o Ability to squat/kneel frequently during set-up duties and rarely during the assembler duties.
o Requires ability to reach 100% of the shift.
o Requires full range of motion to frequently bend at waist.
o Frequent twisting of the torso when wrapping and building trays.
o Frequent lifting/carrying of weights up to 25 pounds, frequent push forces up to 25 foot-pounds at average walking speeds. Occasional lifting/carrying of weights between 26 pounds and 50 pounds, occasional push forces between 26 foot-pounds and 50 foot-pounds at average walking speeds. Rare lifting/carrying of weights greater than 51ft-lbs, rare push forces greater than 51foot-pounds at average walking speeds. All weights and forces can be carried over short and long distances. *The reason for the push forces and average walking speeds is because force is impacted by acceleration. The faster the acceleration, the greater the force.
o Frequently works above shoulders when performing set-up duties; assemblers rarely perform work above the shoulders.
o Grasping and fine manipulation is required 100% of the shift to work with small medical components.
o Specific vision abilities required by this job include close vision, peripheral vision, and the ability to adjust focus.
o Ability to scrutinize moving product to determine defects.
o Must comply with company hygiene and gowning requirements as defined in the Department Operating Procedures, ¿Gowning Requirements and Basic Hygiene for Warehouse, Assembly, Clean Room and Boxing Areas¿.
o Must be able to withstand exposure to isopropyl alcohol used for cleaning.
o Must be able to withstand exposure to latex medical components.


WORK ENVIRONMENT:
o Workstation is primarily in a clean room environment.
o Medical devices containing latex are stored and packaged within the facility; this position requires direct contact with and heavy exposure to latex.