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QC Analyst I

Date: Apr 1, 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

The incumbent is responsible for analytically supporting the Quality Control activities from raw materials to the finished product.  These activities will include but not be limited to raw material/components testing, setting up instruments for testing, physical testing, stability testing, and finished product.

Job Responsibilities

  • Verifying compendial methods.
  • Analytical support for the QC functions and manufacturing.
  • Calibration of analytical instruments.
  • Certification/re-certification of analytical standards.
  • Writing, review and revision of STPs and SOPs.
  • Maintains proficiency with laboratory electronic data acquisitions systems.
  • Procurement assignments/responsibilities.
  • Other responsibilities as assigned by their Supervisor.

Job Requirements

REQUIRED KNOWLEDGE AND SKILLS:

Mathematical Skills:

Ability to calculate figures and commonly used scientific equations.  Additionally, the ability to apply basic concepts in algebra and geometry are required.  Ability to understand and apply certain mathematical models to predict expected behavior.

 

Reasoning Ability:

Ability to solve practical problems and deal with a variety of well-defined variables in situations where only limited standardization exists.  Ability to understand a variety of instructions furnished in written, oral, and diagram or schedule forms.

 

Language Skills:

Ability to read common scientific and technical journals, USP Pharmacopoeia, specifications, standard operating procedures, and standard testing procedures.  Ability to read and write in English as well as to orally communicate in English.

 

Knowledge of:

FDA, cGMPs, and SOPs related to job requirements.

 

PHYSICAL REQUIREMENTS AND WORKING CONDITIONS:

The physical demands and working conditions described here are representative of those that must be met by an employee to successfully perform 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 position, the incumbent is frequently required to walk and sit.  The incumbent is occasionally required to stand; use hands and fingers, handle or feel; reach with hands and arms; stoop, kneel and crouch.  The employee must frequently lift or move up to 10 pounds and occasionally lift and move up to 25 pounds.  Specific vision abilities required by this job include distance vision, color vision, peripheral vision, depth perception, and ability to adjust and focus.

 

Able to pass a respiratory test or a respirator fitting test.

 

While performing the duties of this job, the employee may be exposed to fumes or airborne particles and toxic or caustic chemicals.  The noise level in the work environment is usually moderate.

 

MINIMUM QUALIFICATIONS:

Requires an Associate degree in chemistry or higher (or related field) and normally requires of 0-2 years of QC laboratory in a pharmaceutical setting.

A combination of education, training, and experience can be considered as requirement for this position.                                                                                                                                                                      

 

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