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This position is responsible for performing operations related to the manufacturing of drug products through equipment set-up, operation, clean-up and maintenance in compliance with all regulatory requirements and company policies and procedures.
This position is to work in our Manufacturing Department from 3rd Shift, Monday through Friday 10:00 pm to 6:30 am.
ESSENTIAL AREAS OF RESPONSIBILITY
• Responsible primarily for set up, changeover and operation of fluid bed and/or encapsulation. Additional duties include, but not limited to, mixers, granulators, dryers, mills and tablet compression.
• Responsible for demonstrating consistent and proficient performance in certified areas of operation as applicable.
• Responsible for demonstrating consistent and proficient performance on routine troubleshooting of machine parts and equipment in certified areas of operation as applicable.
• Responsible for training lower level technicians to perform manufacturing operations as applicable.
• Responsible for cleaning facilities, equipment and utensils as required following written Standards Operating Procedures and Work Instructions.
• Responsible for completing documentation as required in the manufacturing of product and the cleaning of facilities and equipment, following cGMP’s and good documentation practices.
• Responsible for reporting and/or escalating any conditions or problems that may affect the quality or integrity 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.
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.
• Requires fluid bed and/or encapsulation experience in industries such as pharmaceutical, food processing or chemical manufacturing.
• Prefer Teva certification in one or more MFG and/or PKG operations as applicable for position.
Skills/Knowledge/Abilities:
• Basic computer skills with working knowledge of MS Office products, Learning Management Systems (LMS), ERP systems such as SAP or Oracle and manufacturing/quality systems such as Trackwise and Qdocs.
• 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 production equipment.
• Detail oriented with ability to identify errors and/or inconsistencies while performing tasks.
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.
• Fingering – using fingers 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 – up to 25 lbs, 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.).
We offer a competitive benefits package, including:
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
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