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Sterile Material Handler, 3rd Shift

Location: Somerset, New Jersey
Date Posted: 03-21-2018
Summary:
The purpose of the Sterile Material Handler is to assure sterile commodities are delivered into the sterile filling area in an aseptic manner per the governing SOP’s.  Commodities should be aseptically received in the filling area in a timely fashion to assure continuation of the production fills.  The Sterile Material Handler is responsible for the following duties:
 
Responsibilities: 
  • Deliver sterile materials into the cleanrooms.
  • Empty the autoclaves
  • Receive commodities from the ware house and pass into the cleanroom via the material in pass thru
  • Remove equipment and commodities from the cleanroom at the end of a production run
  • autoclave
  • Must be detail oriented with the ability to work within a team environment or independent if required.
  • Become and remain gown qualified.
  • Disinfect, deliver and stock gowning components to the gowning room.
  • Prepare, weigh and package raw materials (powder) for contract sterilization.
  • Prepare filter wetting solution and bubble point test Hydrophilic and Hydrophobic filters for manufacturing.
  • Perform reconciliations of components, drug products, and associated materials as per defined procedures.
  • Follow aseptic gowning procedures.
  • Participate in the end of fill process including weighing, recording and attaching data or records to batch record.
  • Set up/preparation/ cleaning and autoclaving components used in aseptic manufacturing operations (some lifting required, up to 55-60 lbs.) 
  • Some Saturdays, Sundays and weekly overtime will be required to work by the company based on the department’s schedule.
  • Cleaning and sanitization of the aseptic production areas, including filling room sanitization between runs.
  • Must document sanitization activities in log books, forms etc. in a legible manner as per the cGMP.
 
Additional Responsibilities:
  •  Must coordinate with production department senior operators to ensure all production activities are performed and production demands are satisfied. 
 
Qualifications: 
  • High School Diploma or GED required with 3-5 years experience in Pharmaceutical manufacturing.
  • Ability to perform all responsibilities listed above.
 
  • Read write and speak the English language fluently.
  • Strong communication skills.
  • The ability to manage multiple operations, simultaneously during routine duties.
  • Understanding of the metric weight system.
  • Ability to meet attendance standards.  All full-time employees are required to work a 40-hour week.
 
Physical Demands, Mental Requirements, and Work Environment:
 
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations must be made to enable individuals with disabilities to perform the essential functions.
 
While performing the duties of this job, the employee is regularly (more than 50%) required to stand, walk, stoop, kneel, crouch or crawl.  The employee is frequently (25% to 50%) required to use hands to finger, handle or touch, reach above shoulders, talk or hear and taste or smell. The employee must occasionally (up to 25%) sit, and climb or balance.   The employee must regularly lift and/or move up to 10 lbs and frequently lift and/or  move  up to 25 lbs and occasionally lift and/or move up to and more than 60 lbs. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to adjust focus.
 
AW
 
 
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