Specialist, QA Compliance

Date: May 18, 2019

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

Follows investigation and audit procedures, participates in investigations (Internal as well as external) and routs associated files for approvals, reviews and files applicable investigation document appropriately.  Log all applicable investigations records and perform data entry in applicable reports and develop graphs of trend data.  

Job Responsibilities

  • Provides support during internal or external investigation performed on site.
  • Supports the updating and managing of audit process and procedures.
  • Initiates documentation associated with Investigation and CAPA records.
  • Assign numbers to Investigation and CAPA records.
  • Routes investigations for review, approval, and archiving.
  • Track status of Investigation, CAPA, and follow-up with owners to assure timely actions and completion.
  • Communicates closure of investigation and CAPAs to organization.
  • Follow Investigation and CAPA procedures in order to monitor and trend investigation data.
  • Log and data entry of Investigation and CAPA information.
  • Develop and distribute Investigation and CAPA report on a weekly basis.
  • Develop and distribute reports and graphs as requested for trending purposes.
  • Experience developing reports and creating investigation files.
  • Other duties as assigned by the manager.

Job Requirements

      Qualifications: 

  • Strong knowledge of personal computer and databases such as MS Office, Word, Excel, and Power point.  
  • Experience Working with cGMP procedures in a Pharmaceutical and or Combination Device manufacturing facility. 
  • Experience managing investigation, CAPA process and writing Quality reports. 
  • Demonstrated ability of having cross functional / team experience.
  • Communicates well.
  • Demonstrated Technical writing skills 

    Language Skills:

  • Ability to understand and follow operating procedures, in order to perform data entry and develop reports.  Must be able to effectively present information and respond to questions from management and/or peers.  Must be able to read, write, and speak English proficiently.

    Mathematical Skills:

  • Ability to read, creates, and interprets charts.   Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

    Reasoning Ability:

  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

    Minimum Education/Qualifications:

  • Associate Degree in Science, Business Administration or Healthcare Administration with 0 – 2 years of experience, or high school diploma with 3 – 4 years of experience with cGMP, CAPA, investigation process and regulated pharmaceutical/medical device industry practices. 

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

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