Operator I

Operator I Shift time: Mon-Thurs 5:00 am to 3:00 pm. Pay Rate: $23.00/hr Contract Period: 6 Months Core Essential Skill Set: Used to working in a fast-paced working environment. Ability to lift and push upto 2500KG’s in an 8-hour shift. routinely lift up to 25 lbs, occasionally up to 50 lbs and more than 50lbs with assistance. They have to have a High School Diploma. Attention to Detail, Ability to follow directions, Strong understanding of the English language (written and verbal), Good communication skills (written and verbal), good math skills, Dependability with punctuality and attendance. Screenings: Basic BKG 11 Panel Drug + Fentanyl Medical Screenings A) Vision Screen – Near, Far, Color, Depth and Peripheral B) Vital Signs C) Urine Dip Analysis D) Whisper Test E) Audiogram & Noise and Hearing Questionnaire (remove for office or lab personnel) F) Spirometry & OSHA Respirator Questionnaire (remove for office or lab personnel) G) Lifting Assessment 30 pounds

POSITION SUMMARY

This position is responsible for performing operations related to the manufacturing and/or packaging of drug products through equipment set-up, operation, clean-up and maintenance in compliance with all regulatory requirements and company policies and procedures.

ESSENTIAL AREAS OF RESPONSIBILITY

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments. Responsible for learning the manufacturing and/or packaging process as assigned by following approved batch records (BR), work instructions (WI), standard operating procedures (SOP), etc. Responsible for set up, changeover and operation of various manufacturing and/or packaging equipment including, but not limited to, mixers, granulators, dryers, mills, tablet compression, holder assemblers, blister formers and sealers, packagers and labelers. Responsible for cleaning of facilities, equipment and utensils as required following SOP’s and WI’s. Responsible for completing documentation as required in the manufacturing and/or packaging of product. Responsible for completing all training requirements and maintaining compliance with all assignments. Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions. Responsible for performing additional related duties as assigned.

POSITION REQUIREMENTS

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered. Education/Certification/Experience: Requires High School Diploma or equivalent. Strongly prefer previous experience in a manufacturing environment within pharmaceutical, medical device, nutraceutical or food processing industries. Strongly prefer previous experience setting up production equipment and/or running production lines. Requires basic math skills with addition, subtraction, multiplication and rounding numbers. Skills/Knowledge/Abilities: Experience working with computers (MS Office products) and basic knowledge of MS Office products, LMS, ERP systems, etc. Ability to receive instruction and follow directions. Ability to interact positively with co-workers and management. Ability to communicate effectively with written and oral communication skills. Ability to follow company policies and procedures. Ability to follow cGMP and other regulatory requirements. Ability to operate and troubleshoot manufacturing equipment. Problem Solving: Works on assignments that are routine to semi-routine in nature where the ability to recognize deviation from accepted practice is required. Exercises judgment within specifically defined practices and policies and selects methods and techniques for obtaining solutions. Normally receives general instruction on routine work and detailed instruction on new assignments. May be asked to recommend methods and procedures for problem resolution.

PHYSICAL REQUIREMENTS:

Constant: Standing for extended periods of time at work station or equipment. Walking to move short distances quickly and frequently. Using fingers to perform activities such as picking, pinching or typing. Frequent: Stooping, Kneeling and/or Crouching – bending body, spine and/or legs. Twisting/Reaching – turning at waist and extending hands and/or arms in any direction. Occasional: Sitting for extended periods of time at work station or mobile equipment. Climbing – use of feet, legs, hands and/or arms to ascend or descend. Crawling – using hands and knees or hands and feet to move about. Pushing and/or Pulling – using upper extremities to exert force. Grasping – applying pressure to an object with the fingers and palm. Repetitive Motions – frequent motions of the wrists, hands and/or fingers. Lifting – raising from lower to upper and/or moving objects horizontally – routinely up to 25 lbs, occasionally up to 50 lbs and more than 50 lbs (with assistance). Visual Acuity: Perform activities such as operating machines (i.e. lathes and drill presses) where the seeing job is at or within arm’s reach. Perform activities such as computer work, preparing and analyzing data, extensive reading, visual inspection involving small defects, small parts and/or operation of machines (including inspection), using measurement devices and/or assembly or fabrication of parts at a distance close to the eyes. Operate motor vehicles or heavy equipment.

WORKING ENVIRONMENT

Constant exposure to moving mechanical parts and/or moving equipment. Frequent exposure to moderate to loud noise levels. Frequent exposure to fumes, odors, dusts, mists and/or gasses. Frequent exposure to vibrations. Occasional exposure to wetness depending on assigned process. May be required to wear personal protective equipment (PPE) as needed for assigned process (i.e. safety glasses, respirator, hearing protection, gloves, etc.). #J-18808-Ljbffr Kelly Services-Portugal