drjobs Quality Assurance Associate

Quality Assurance Associate

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1 Vacancy
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Job Location drjobs

Malvern, PA - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Description

Title:

Quality Assurance Associate

Job Purpose:

To mainly provide support to the CAPA System Trainings and Vendor qualification process and records review.

Main Duties and Responsibilities:

  • Maintain the culture of the importance of an integrated quality system within the company
  • Trainer of topics related to Quality for vendors and MKN employees
  • Support in THE CAPA System
  • Completion of investigations via effective investigation of deviations and the development of effective action plans
  • Completion of CAPAs and Effectiveness Checks
  • Preparing deviation reports
  • Support the Vendors Qualification process
  • Assist with the Document Control process
  • Maintain quality policies and procedures in accordance with company requirements
  • Evaluate and approve documents according to the organizations standards and local regulations
  • Instructions / SOP creation and review
  • Collaborate with the logistics team to monitor the entire process ensuring the effectiveness and compliance of all operations
  • Support quality audits and clients Marken qualification processes

Requirements:

  • Bachelors degree in life sciences or related field
  • Minimum 3 years of relevant experience including Quality and Logistics experience in Pharmaceutical/ biotechnology industry
  • Previous experience in Quality Management Systems with an eye for details
  • Knowledge of GxP
  • Good interpersonal skills conflict mediation sense of urgency to complete assignments on time
  • Ability to analyze and work in detail

Marken is a wholly owned subsidiary of UPS and is a critical part of UPS Healthcare. Marken offers a stateoftheart GMPcompliant depot network and logistic hubs for clinical drug product storage and distribution worldwide and supports cell and gene therapy logistics services from clinical to commercial while maintaining the leading position for DirecttoPatient and Home Healthcare services biological sample shipments and biological kit production.

Moving Our World Forward by Delivering What Matters.


Required Experience:

IC

Employment Type

Full-Time

Company Industry

About Company

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