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Sanitization Associate I

Company: Akorn, Inc.
Location: Somerset
Posted on: June 10, 2021

Job Description:

Job Description

SUMMARY:

All Sanitization Associates are responsible for all activities associated with the manufacturing and filling operations, required to produce sterile drug products under aseptic conditions.

ESSENTIAL FUNCTIONS:

Include the following. Other duties may be assigned.

  • Compliance with associated SOPs and training requirements
  • Removal of used scrubs and coveralls into appropriate bins
  • Stocking of consumable items, such as bouffant hats and beard covers
  • Stocking of sterile and non-sterile gowns
  • Transport supplies into controlled areas from warehouse
  • Disposal of controlled area trash into appropriate bins
  • Cleaning and sanitizing aseptic production areas
  • Reading and understanding written instruction as detailed on production batch records
  • Refilling Bootie Butlers, replacing/changing floor mats
  • Cleaning and performing basic dish washing solution equipment components
  • Prepare for aseptic gowning qualifications. NOTE: Must have flexibility, discipline and not fall out of established limits.
  • Basic understanding of personnel, equipment flow and controlled environments
  • Must document activities in log books, forms etc. in a legible manner as per cGMP
  • Must be able to work until all cleaning activities are complete
  • Must be available for overtime and weekend

ADDITIONAL RESPONSIBILITIES:

Required to assist in packaging operations as needed in the event of manpower shortages

Qualifications

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION AND EXPERIENCE:

High School Diploma or GED required along with experience in pharmaceutical processing. One year pharmaceutical experience, preferably in Aseptic manufacturing.

JOB PREREQUISITES:

  • Read, write, and speak the English language fluently.
  • Working knowledge of the metric system used for component preparation.
  • Must be detail oriented with the ability to work within a team atmosphere or independent if required.
  • Ability to meet attendance standards. All full-time employees are required to work a 40-hour week, most of which has to be during "regular" business hours. Must be able to work extended hours during the week depending on the work load. Must also be available to work weekends.

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.

Mental requirements include:

  • Ability to apply deductive reasoning and understand complicated issues.
  • Ability to receive instructions and follow work rules and company policies.
  • Ability to follow safety and security practices.
  • Ability to meet deadlines and effectively deal with office stress.
  • Ability to accurately communicate ideas, facts and technical information.
  • Maintain confidentiality of certain information.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently required to work near moving parts and exposed to fumes or airborne particles. The employee is occasionally exposed to wet, humid conditions, toxic or caustic chemicals, outdoor weather, extreme cold, extreme heat, risk of electrical shock, vibration and moderate noise.

Keywords: Akorn, Inc., Trenton , Sanitization Associate I, Other , Somerset, New Jersey

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