QA Associate I - Marken

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Job Description

Main Purpose:

The Quality Assurance Associate I (QAA I) is responsible for the oversight and implementation of the Marken Quality Management System (QMS), Marken Standard Operating Procedures (SOPs), processes and policies. The QAA I also needs to ensure compliance with applicable regional and local regulations and requirements, and customer requirements as appropriate, but not limited to: current Good Manufacturing Practice (GMP), Good Distribution Practices (GDP), Good Clinical Practices (GCP), Good Storage Practices (GSP), ISO 13485 and ISO 9001.

Main Duties And Responsibilities

  • Implement, communicate and maintain company’s quality systems, in compliance with Marken’s Global QMS requirements.
  • Interact with clients on Quality Assurance (QA)/ GxP related matters under management supervision.
  • Effectively interact with Marken Departments and stakeholders to maintain that all QA tasks are appropriately supported by QA.
  • Support on internal audits.
  • Support client audits and regulatory inspections, including the preparation of appropriate materials required within those audits when applicable.
  • Responsible for the QTA process, including ownership of the QTA from initiation of the QTA template through to final signatures and filing; assigning a QTA # and PRA # if applicable, and assuring compliance to the SOP, including ensuring a QTA is updated or retired appropriately.
  • Collate issues, CAPA, Risk Assessment, Change Control and training metrics and identify quality improvement initiatives. Oversee activities that conclude on the appropriate close-out of all CAPA entries.
  • Identify relevant GxP/ Quality related training needs and deliver training where required.
  • Ensuring that the Marken Quality System and GxP Program are implemented and maintained.
  • Ensuring the accuracy and quality of records and documents.
  • Participate actively in all the internal Quality and/ or designated meetings.

General

  • Perform activities assigned by QA Management.
  • Travel as reasonably requested by the Line Manager to the performance of duties.
  • Support your line manager, that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.
  • Adhere to Good Manufacturing/ Distribution / Clinical Practices
  • Undertake any other reasonable duties at the request of the Line Manager
  • Adhere to company Policies at all times.

Employee Type

Permanent

UPS is committed to providing a workplace free of discrimination, harassment, and retaliation.

Seniority level

  • Seniority level

    Entry level

Employment type

  • Employment type

    Full-time

Job function

  • Job function

    Quality Assurance

  • Industries

    Truck Transportation

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