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QA Associate III

Date: Feb 21, 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

Responsible for the review of clinical, R&D, and Production commercial batch records to ensure compliance with cGMP's, company procedures and regulatory commitments. Perform SAP transactions as part of the product disposition procedure, and create product release summary requirements.

Job Responsibilities

  • Attend scheduling meeting to coordinate material release priorities.
  • Review, approve and release manufacturing, packaging and clinical batch records and auxiliary documentation.
  • Prepare product release summaries, and create Certificate of Analysis, Certificate of Compliance, and Certificate of Manufacture as applicable for each product batch.
  • Perform reviews for QC lab folders for each manufacturing stage for compliance against the respective specification.
  • Conduct SAP and necessary database transactions as part of the release procedure. Monitor trend charts.
  • Create product flow charts for applicable batches as required.
  • Audit transactions for the controlled substances database.
  • Prepare Product Release documentation for batches in support of annual product review requirements.
  • Assist with client audit questions for the product release group.
  • Ability to work with mathematical concepts such as fractions, percentages, ratios, and proportions to practical situations
  • Prepare monthly reports for product release group.
  • Notify planning and appropriate departments if there are open SMR’s or investigations needing closure prior to batch release.
  • Communicate any potential delays in release of batches for manufacturing, R&D or commercial distribution.
  • Notify manager of any non-compliance, out of accountability/yield range observed during batch record review process.
  • Write and revise Standard Operating Procedures and Product Specifications for the area.
  • Perform ongoing training with department staff as it relates to the area.
  • Assistance for variance investigation reports and special projects as required.
  • Ability to write reports, and correspondence.
  • Other duties as assigned by the manager.

Job Requirements

Qualifications:  To perform this job successfully, an individual must be able to perform each essential job function satisfactorily. Must have existing knowledge, experience and understanding of Current Good Manufacturing Practices (cGMP), 21 CFR part 11, and other regulatory requirements. Knowledge of personal computer hardware, software, and databases (MS Office, Trackwise, SAP, Empower 2, SLIM) is desirable. The requirements listed below 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.

 

Language Skills:

Ability to read, analyze, and interprets general business periodicals, professional journals, technical procedures, or governmental regulations.  Ability to write reports, business correspondence, and procedure manuals.  Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

 

Mathematical Skills:

Ability to work with mathematical concepts such as probability and statistical inference. Ability to read, create, and interpret Statistical Process Control (SPC) Charts. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

 

Reasoning Ability:

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

 

Physical Demands:

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 may be made to enable individuals with disabilities to perform the essential functions.

 

While performing the duties of this job, the employee is regularly required to sit.  The employee frequently is required to talk or hear.  The employee is occasionally required to walk and use hands to finger, handle, or feel. 

 

 

Work Environment:

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.

 

The noise level in the work environment is usually moderate.

 

Minimum Qualifications:

B.A./B.S. degree or equivalent and three to five years related experience, 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