Production Technician II

SUMMARY

Production Technician II performs duties in all areas of operations to produce PTS products, using progressive skills and knowledge of the manufacturing process.   This position will follow work instructions for assembly of PTS products in various operations areas and departments.  This position requires the ability to document the manufacturing process to meet all standards for product safety, quality, and efficiency.    In this position you will perform required duties to ensure regulatory compliance standards of PTS products.    

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Ensure production area is safe to work in and has necessary inventories and tools to keep production running.
• Complete daily assigned tasks to meet production volume, quality levels, and schedule.
• Prepare and Assemble product according to established work instructions.
• Apply company policies and work instructions procedures to complete assignments.
• Treat peers and supervisors with respect.
• Be a team member in the assembly of PTS products.
• Other duties as assigned by Supervisor or Lead. 
• Can Set-up, operate, and train others on multiple basic manufacturing equipment or work centers.
• Support the set up and operation of multiple complex manufacturing equipment.
• Conduct quality inspections on finished products and input materials for quality and adherence to PTS specifications.
• Can work in more than one department (meters, packaging, manual, automation, A1CNow, CardioChek, etc.)  as directed by the supervisor(s).
• Prepare and verify materials to be used as issued to work orders. 
• Understands and can make decisions to meet production goals and criteria for equipment yield and efficiencies to meet the production schedule.
• Understands the process flow among multiple process steps.
• Has investigation skills and executes basic troubleshooting on equipment and workstations before notifying maintenance.
• Can give accurate feedback and progress updates to Lead or Supervisor on production metrics.
• Support paperwork, forms, work orders, and batch records of production.
• Has the ability to learn and apply lessons from training and verbal instruction and teach and train peers.
• Effective verbal communication skills with Maintenance and Manufacturing Engineering groups to be able to accurately explain downtime problems/issues.
• Monitor machines and inform Supervisor, Lead, and/or Tech III of problems. 

ESSENTIAL DUTIES AND RESPONSIBILITIES (cont.)

• Perform in-process inspection of components and assemblies to verify quality conformance.
• Clean and maintain equipment and work area as needed.
• Recognize any minor issues from the equipment and any affiliated documentations and take appropriate corrective action within scope. 
• Demonstrates dedication and flexibility to ensure production runs smoothly.

QUALIFICATIONS 

• Ability to lift approximately 25lbs.
• This position may require irregular and extended hours of work, so the person hired must be capable of meeting the varied work hours.  
• Understands Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP)
• Must be a team player.
• Ability to clearly and effectively communicate with peers, supervisors, and leads.
• Effective verbal and written communication skills
• Ability to pay close attention to detail.
• Basic Computer Skills
• Ability to solve basic math problems

EDUCATION and/or EXPERIENCE 

• High school diploma or general education degree (GED)
• One to two years related experience in Manufacturing in the medical device, pharmaceutical or biotech industry, or equivalent combination of education and experience.
• Experience in an FDA regulated environment is preferred 

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  While performing the duties of this job, the employee is regularly required to use hands to touch, manipulate, handle, or feel production items or materials repetitively.  The employee frequently is required to stand and/or sit for extended periods of time.   The employee is required to reach with hands and arms.  Specific vision abilities required by this job include close vision. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Lab coat, safety glasses, hair nets, gloves, and other PPE are required in production rooms based on the function and task.  Most production rooms are kept at a controlled temperature and humidity for assembly of PTS products.

EQUAL OPPORTUNITY EMPLOYER

PTS Diagnostics is an Equal Opportunity and E-Verify employer. Employment decisions for all applicants and employees will be made without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, age, national origin, marital status, veteran status, disability, or other characteristics protected under local, state, or federal law.

QUALITY COMMITMENT

This position requires compliance to applicable quality system and regulatory requirements. This individual adopts a “quality in everything we do” approach to all aspects of the execution of responsibilities of this position. Through vigilance, this individual remains alert to any potential compliance situations, and must report such observations to managers and the Head of Quality.

STATEMENT of OTHER DUTIES DISCLAIMER

This job description in no way states or implies that these are the only duties to be performed by this employee. This employee will be required to follow any other instructions and to perform any other duties requested by their supervisor.