Operator

The Operator retains the knowledge of the Assembler job description and performs jobs that require several independent steps and evaluations for completion of duties assigned. The employee will become demonstrative in the areas of responsibility including all computer programs that pertain to the individual work areas. This individual will require minimal supervision to perform his/her tasks and comply to all c GMP standards, in order meet production schedules, set forth by management.

Tasks/Duties/Responsibilities:

• All assembler duties.
• In addition to the ability to perform routine tasks; develop mechanical aptitude in areas of
  assignment.
• Be able to work independently and assist Assemblers.
• Operate automated production equipment with minimal supervision.
• Correctly read and follow detailed production procedures and provide feedback for
  procedural and process improvements.
• Independently perform calibrations and routine process monitoring as needed.
• Monitor and requisition inventory for the purpose of fulfilling production needs for the
  required department.
• Learn how to troubleshoot all equipment and automation in the respective department
  with the support of Maintenance or Engineering
• Become proficient in using all computer programs necessary for the required
  department.
• Train other employees as required.
• Must be able to work independently as well as collaboratively in a team setting with
  peers in a cross departmental setting.
• Some supervisory attention may be required at this level.
• Other duties as required.

Job-Specific Responsibilities (but not limited to):

Kit Assembly

• Utilize balance to conduct weight checks
  
• Perform a variety of duties including dispensing of solutions, labeling bottles and tubes, setting up filling/labeling machines
  
• Run automated equipment with limited help from senior operators including; trouble shooting equipment for jams, label defects, capping defects and working proficiently with HMI's.

Sensor Assembly

• Set-up and operate dispensers, oven/dryer and cutting machines
  
• Ability to make minor adjustments to machines as needed.
  
• Operation of software via menus and programs for computer controlled dispensing equipment and labelling as prepared by others.
  
• Utilize balance to conduct weight checks of dispensed solutions.
  
• Ability to print SOP's and applicable forms as needed.

Analyzer Assembly & Test

• Perform all assembler level duties.
• Perform a variety of assembly operations associated with instrument production, which include hand assembly of components onto printed circuit boards; forming, clipping and soldering wire leads on boards
  
• Assembling various sub-assemblies, cables, wiring, etc., onto boards; assembling standard harnesses; attaching/soldering or crimping wires to various unit/instrument sub- assemblies.
  
• Assist in investigative studies into production, supplier and design problems and perform studies related to new products as needed and provide the required documentation.
  
• Compile test data on all conducted tests, prepare and maintain complete records on all tests.
  
• Perform close clearance soldering and optical assembly work necessary to build the instruments.
  
• Take inventories, complete transaction forms and maintain rework documents for the new and refurbished instruments.

Other Duties/Physical RequirementsDuties/Physical Requirements

• High School Diploma or general education degree (GED) required.
• A minimum of 2 years prior manufacturing and/or assembly experience required.
• Prior experience in an FDA regulated production environment preferred. · Proficiently demonstrate good documentation practices.
• All Assembler Skills
• Proficiently demonstrate good documentation practices.
• Must be a self-starter, detail oriented, organized and able to perform under pressure in a
  fast-paced environment.
• Demonstrate interpersonal, organizational, comprehension, written and oral communications skills and the ability to lead others.
• Demonstrate problem solving and troubleshooting skills.
• Documented training for setup and operation of equipment (as assigned by supervisor).
• Must be able to demonstrate/ be competent in multiple skills in 2 total departments, listed
  within the Job Specific responsibilities above, through cross-training over several
  departments as instructed by management.