Operator 2, Machine

Performs routine production functions including filling, utility operations, packing, packaging, assembling, labeling and inspecting under general supervision. Maintains accurate records and logs in accordance with FDA (Food and Drug Administration), GMPs (Good Manufacturing Practices) and ISO9000 (International Organization for Standardization). Effectively works in a team setting, supporting team goals and objectives. Makes effective decisions relative to position requirements. Must follow instructions and work within routine, standard practices, making decisions as required. Works under direct supervision, following standard operating procedures. High school diploma or equivalent. One to two years' experience. Develops skills in basic tasks, techniques and procedures within one skill area / process / method. Applies basic knowledge and skills to complete routine tasks consisting of prescribed steps. Effective communication skills at a level co-workers and Team Lead/Supervisor can understand. Ability to read, write, interpret and comprehend specifications written in English and perform basic math calculations. Must be able to work flexible and/or extended hours and report to work on a regular, punctual basis. Ability to get along with people and be able to work in a team environment. Willingness to rotate into different tasks and responsibilities.

Machine Operator 2

Job Overview

Performs routine set up, operation, minor routine maintenance, preventative maintenance (PM) and troubleshooting of moderately complex/automated manufacturing equipment. Controls and adjusts machine settings. Inspects in-process parts to ensure consistent quality and removes defective product, packaging, and component material. Assists with root-cause analysis activities for process or product exceptions. Checks work using prescribed gauges, jigs and fixtures to measure close tolerances. May monitor quality in accordance with statistical process or other control procedures. Ensures accurate documentation of all relevant quality, safety, and maintenance documents. Identifies, troubleshoots, and resolves basic issues associated with the machine performance and/or product quality.

Responsibilities and Duties

o Works within standards and operating procedures to plan, perform, and make decisions regarding the set up and operations of a variety of production equipment, including automated machine processes and controls to perform routine assembly-line production functions of filling, packing, assembling, labeling and inspecting

o Uses independent judgment in troubleshooting and problem solving under general supervision

o May perform clean up functions in sterilized areas

o Identifies the need for minor equipment repairs

o May analyze and evaluate charts, follows simple diagrams, testing, and inspecting procedures

o Assists with root-cause analysis activities for process or product exceptions

o May monitor quality in accordance with statistical process or other control procedures.

o Ensures accurate documentation of all relevant quality, safety, and maintenance documents. Identifies, troubleshoots, and resolves basic issues associated with the machine performance and/or product quality.

o Demonstrates the ability to follow established procedures according to Good Manufacturing Practices (GMP)

o Must follow all Client housekeeping policies and procedures

o Must follow all Client safety policies and procedures

o Must be able to work overtime as required to meet Client business requirements

o Perform other duties as required

Qualifications

Minimum Education/Experience:

o High school with 2 years manufacturing. Experience in a regulated environment preferred.

o AA technical degree with 0 years' experience

Basic Skills:

o Can effectively work in a team setting and communicate effectively across the department

o Strong attention to detail

o Ability to be punctual in order to ensure production

• Ability to work on assignments that are semi-routine in nature with the skill to recognize any deviations from specification
• Ability to operate independently within the constraints of approved process-related documentation

Proficient/Working Skills:

o Must be proficient in English with the ability to read, write, analyze/evaluate charts, follow simple diagrams and perform basic arithmetic

o Basic proficiency with PCs (Personal Computers) and basic use of a Windows environment is required