Production Operator 1

Burke Porter, an Ascential Technologies Brand; Ham Lake (MN); On-site; USD 40,000 - 50,000; Full time

Job summary

Burke Porter, an Ascential Technologies Brand in Minnesota is seeking a Production Operator to assemble medical and combination devices in a class 7-8 cleanroom, operating automation and inspecting parts. Responsibilities include following GDP/GMP, maintaining cleanliness, and documenting procedures with accuracy.

The role requires high school diploma or GED, reading English procedures, strong communication, reliability, and the ability to stand or sit for long periods.

Qualifications

• Must have a high school diploma or GED.
• Must be able to read and comprehend procedures written in English.
• Must have strong written and verbal communication skills.
• Must have reliable transportation.
• Must be able to sit and/or stand for a minimum of 4 hours at a time.
• Must have excellent fine motor skills and hand dexterity.
• Must have excellent attention to detail.

Responsibilities

• Assemble products per NACS processes and procedures with accuracy.
• Correctly document completed procedures by initialing and dating with GDP.
• Correctly document and communicate nonconformances.
• Follow clean room processes and procedures with accuracy.
• Follow production processes and procedures with accuracy.
• Follow safety related processes and procedures with accuracy.
• Follow production schedules as directed.
• Collect components and supplies as directed.
• Assist in the sampling of material.
• Complete required GMP cleaning to maintain clean and compliant facility.
• Other essential responsibilities as assigned.
• May support in line clearance activities.
• May handle hazardous materials with proper PPE.
• May assemble with the use of small hand tools.
• May operate automation equipment.
• May package and label product.
• May provide information to the quality department for root cause analysis.
• May assist the Lead Production Operator and Supervisor to resolve issues.
• May provide minimal equipment maintenance as directed.
• May provide hands on job function training/support to coworkers as directed.
• Complete required trainings applicable to job requirements
• Other additional responsibilities as assigned
• Perform duties following NACS, Inc. quality and safety standards
• Participate in team building, training, and department communications
• Understand and follow all attendance related policies
• Maintain a high level of personal and professional integrity
• Perform additional job responsibilities as assigned

Skills

Attention to detail

Fine motor skills

Reading procedures

Verbal/written communication

Reliability

Education

High school diploma or GED

Job description

SHIFT TIMES

5:00am - 3:30pm (Monday - Thursday) OR 10:00am - 8:30pm (Monday - Thursday)

Summary

A Production Operator is responsible for several aspects of the production including material handling, equipment operation, process monitoring, quality control, with the primary responsibility of assembling medical and combination devices. The majority of a Production Operator’s time will be spent working inside a class 7-8 cleanroom operating automation, and physically assembling and inspecting parts. The Production Operator’s specific responsibilities can change regularly based on the production needs.

Essential Responsibilities

• Assemble products per NACS processes and procedures with accuracy


• Correctly document completed procedures by initialing and dating with GDP


• Correctly document and communicate nonconformances


• Follow clean room processes and procedures with accuracy


• Follow production processes and procedures with accuracy


• Follow safety related processes and procedures with accuracy


• Follow production schedules as directed


• Collect components and supplies as directed


• Assist in the sampling of material


• Completes all administrative functions relating to business or regulatory requirements


• Complete required GMP cleaning to maintain clean and compliant facility


• Other essential responsibilities as assigned

Additional Responsibilities

• May support in line clearance activities


• May handle hazardous materials with proper PPE


• May assemble with the use of small hand tools


• May operate automation equipment


• May package and label product


• May provide information to the quality department for root cause analysis


• May assist the Lead Production Operator and Supervisor to resolve issues


• May provide minimal equipment maintenance as directed


• May provide hands on job function training/support to coworkers as directed


• Complete required trainings applicable to job requirements


• Other additional responsibilities as assigned

EXPECTATIONS

• Perform duties following NACS, Inc. quality and safety standards


• Participate in team building, training, and department communications


• Understand and follow all attendance related policies


• Maintain a high level of personal and professional integrity


• Perform additional job responsibilities as assigned

Qualifications

Below are the guidelines for education, knowledge, skill, and/or abilities need to perform each essential duty satisfactorily. Reasonable accommodations will be considered for individuals who are unable to meet the required qualifications.

• Must have a high school diploma or GED


• Must have the ability to read and comprehend procedures written in English


• Must have strong written and verbal communication skills


• Must have reliable transportation


• Must be able to sit and/or stand for a minimum of 4 hours at a time


• Must have excellent fine motor skills and hand dexterity


• Must have excellent attention to detail

Preferred

• 1-2 years of experience in medical assembly


• 1-2 years of experience working in a clean room


• Working knowledge of GMP and GDP