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QA Specialist – Risk management

  1. United States
Maryland
  1. Contract
Competitive
  1. Compliance / Quality Assurance
30-10-2023
31981

This vacancy has now expired

QA Specialist – Risk management – 6-Month Contract

Are you looking for the opportunity to work with a global biopharmaceutical company? This is your chance! Our client develops and delivers life changing medicines to millions of people globally and as part of their growth, they are looking for a QA Specialist to help support operations at their Maryland facility.

With their Drug Substance (DS) manufacturing network growing rapidly, they are committed to growing their portfolio of commercial biologics products supplied worldwide – and this is your opportunity to be involved!

Responsibilities will include:
  • Creation, development and maintenance of Quality Management System procedures and training materials pertaining to the Quality/GDP area
  • Handling of Product Quality Complaints, including e.g., internal reporting and responding to external customers
  • Handling of tasks related to deviations, CAPAs, recalls, destructions, returns, risk management, self-inspections and change control
  • Oversight of distributors and outsourced activities
  • Support in the completion of Rpi checks
  • Support with the development and maintenance of the local Quality training program
  • Performing internal/external trainings of personnel
  • Maintaining the subsidiaries in a state of inspection readiness
  • Support with management of audits and inspections of the local office
Qualifications:
  • Completion of a university or other higher education course of study in pharmacy, chemistry, biology, or a related life science preferred
  • Experience from a Quality Assurance position in the pharmaceutical industry (at a minimum eight years)
  • Strong leadership skills and ability to lead your own work
  • Good communication and organisation skills
  • Strong computer skills
  • An understanding of the principles and guidelines of GDP, and personal knowledge of the relevant provisions of all relevant laws, regulations and provisions concerning medicinal products for human use
  • Fluency in English
  • Ability to work in a team which spans across several countries
If this role is of interest to you, please apply now!



The candidate must have the rights to work in the location stated in the job advert.

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