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Manufacturing Operator I

Date: Oct 8, 2021

Location: Miramar, FL, US, 33025

Company: Apotex

 

Aveva Drug Delivery Systems is a global leader offering a full range of research, development, and manufacturing capabilities to produce transdermal pharmaceutical products that can improve the quality of life, usage, and compliance rates for patients.

 

Job Summary

  • Coats blends and adhesives to produce laminate.
  • Prepares finished and slit laminate rolls.
  • Documents operational parameters for manufacturing equipment.
  • Performs on-line coat weight sampling operations.
  • Performs batch record accountability calculations.
  • Documents manufacturing steps performed in the batch record.
  • Weighs and documents the weights of raw materials, components and product intermediates.
  • Complies with current Good Manufacturing Practices, Standard Operating Procedures and safety policies while performing all job duties.
  • Maintains and cleans manufacturing and production areas and equipment.
  • Works with active drug products, adhesives, solvents and various other chemicals to accomplish the tasks listed above.
  • Performs job tasks within production and other departments as needed.

Job Responsibilities

 

  • Coats blends and adhesives to produce laminate.
  • Prepares finished and slit laminate rolls.
  • Documents operational parameters for manufacturing equipment.
  • Performs on-line coat weight sampling operations.
  • Performs batch record accountability calculations.
  • Documents manufacturing steps performed in the batch record.
  • Weighs and documents the weights of raw materials, components and product intermediates.
  • Complies with current Good Manufacturing Practices, Standard Operating Procedures and safety policies while performing all job duties.
  • Maintains and cleans manufacturing and production areas and equipment.
  • Works with active drug products, adhesives, solvents and various other chemicals to accomplish the tasks listed above.
  • Performs job tasks within production and other departments as needed.

Job Requirements

Required Knowledge and Skills:

  • An individual must be able to perform each essential job function satisfactorily.
  • Ability to read English and interpret documents such as safety rules, Standard Operating Procedures batch records and cleaning procedures.
  • Ability to write in English and complete batch record documentation.
  • Ability to speak English effectively.
  • Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals.
  • Ability to compute rate, ratio, percent and to plot and interpret data graphically.
  • Ability to apply common sense understating to carry out detailed written and oral instructions.
  • Some mechanical ability to assemble manufacturing equipment.
  • Knowledge of FDA, cGMPs, and SOPs related to job requirements.

    Physical Requirements and Working Conditions:

    While performing the duties of this job, the employee is regularly required to sit, stand and walk.  The employee is frequently required to use hand to finger, handle or feel; reach with hands and arms; and talk and hear.  The employee is occasionally required to stoop, kneel, crouch or crawl.  The employee must frequently lift and/or move up to 50 pounds.

    While performing the duties of this job, the employee is regularly exposed to moving mechanical parts.  The employee is frequently exposed to fumes or airborne particles and toxic caustic chemicals.  The noise level in the work area is usually loud.

    The employee will be required at times to wear a full face respirator and/or TYVEK or TYCHEM jumpsuits during cleaning operations. You may be required to work additional hours from time to time, including weekends.  Shift hours are subject to change due to operational needs.

     

     

    Minimum Qualifications:

High school diploma or general education degree (GED) plus one to three months related experience and/or training; or equivalent combination of education and experience.

 

At Aveva Drug Delivery Systems, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Aveva Drug Delivery Systems offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.


Nearest Major Market: Fort Lauderdale
Nearest Secondary Market: Miami