QA Specialist

Job Description:

The Quality Assurance Specialist I is responsible for the oversight and implementation of the Marken Quality Management System (QMS), Marken Standard Operating Procedures (SOPs), processes and policies required to manage and control Marken’s Storage, Distribution and Transportation, Kit Production Facility.

The Quality Assurance Specialist I also need 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), ISO 9001, and if applicable for site operations, ISO 13485.

Main Duties and Responsibilities

Implement, communicate and maintain company’s quality systems at the facility, in compliance with Marken’s Global Quality Management System (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 including report preparation and assessment and tracking of associated corrective and preventive actions (CAPA).

Support audits of external service providers as part of the vendor selection process.

Follow up and tracking all commitments for actions or changes made by Marken from previous audits.

Support client audits and regulatory inspections, including the preparation of appropriate materials required within those audits when applicable.

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 or make they are deliver where required.

Ensuring that the Marken Quality System and GxP Program are implemented and maintained.

Assisting in the evaluation of Marken-designated vendors and/or out-sourced activities.

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 the 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.

Employee Type:

Permanent

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