QA Associate

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Job Description:

Company overview

Marken, UPS Healthcare Precision Logistics (formerly Marken, MNX & Polar Speed), the clinical and advanced therapy subsidiary of UPS Healthcare, unites expertise across healthcare and complex secure logistics to drive the success of our clients through innovation.

Main Purpose:

Actively work in the development, implementation and maintenance of an appropriate, effective and measurable Quality Assurance system in compliance with the requirements of Good Manufacturing and Good Storage (GSP), Distribution (GDP) and Transportation Practices for Medicinal Products, Good Clinical Practice (GCP) as well as any applicable laws, rules, guidelines and regulations and Marken’s Standards, as appropriate. Become a Quality agent, acting as a multiplier of company’s Quality Culture and Compliance, by supporting the other departments in the adherence to Marken quality standards in all activities performed.

Main Duties and Responsibilities

• Act as deputy in absence of QA Manager for assigned activities.

• To support the implementation, communication and maintenance of company’s quality system seeking compliance in all activities as required by Marken standards and QMS.

• To track the management of deviations, complaints, audit records, CAPA plans, collation of CAPA data, and identification and implementation of quality improvement initiatives.

• To communicate with clients on QA and GXP matters.

• Assist in internal audits including tracking of associated corrective and preventative actions (CAPA)

• Host or Co-host Client audits and Regulatory Inspections, managing the preparation, interacting with department SMEs, providing evidence and responses and assuming the Marken QA focal point role, as designated by QA Manager.

• Perform internal audits including report preparation and assessment and tracking of associated corrective and preventative actions (CAPA).

• Provide GXP/QA training for Marken employees and vendors where required.

• Review metrics and presentations for monthly review of Quality, Monthly Business Reviews and client Quality Business Reviews and act as QA representative on behalf of QA Manager as assigned.

• Act in support to other activities related to QA tasks and support to Operations department as required by QA Manager.

• Keep informed of regulatory changes in Country/Region and prompt updates to SOPs as needed.

• Perform periodic training review to assist Operations and QA Managers with training oversight.

• Act as QA Document Administrator.

• Attend to any quality meetings as designated by the QA Manager.

• Seek for Good Documentation Practices in all records prepared and reviewed.

• Proactively interact with other company departments providing proper QA support for proper completion of GXP activities.

Specific Duties and Responsibilities – Business line specific:

• Perform a review and release of incoming material receipts in accordance with relevant procedures,

• Perform Quality checks in additional labelling/re-labelling or secondary packaging and destruction activities in accordance with Marken procedures, including WMS transactions as applicable.

• Review and support the execution and oversight of calibration and qualification activities related to devices, equipment, systems and facilities, as applicable per Marken procedures and local regulations.

• Assist with QA reviews of qualification protocols.

• Perform quality checks for as described in the applicable procedures to ensure compliance with the Good Clinical Practices or ISO 13485 standards.

• Coordinate product recall as required and the annual mock recall.

• Assist in local QA Documentation management, including the maintenance of local documents identification, distribution and archive organization.

General

• Ensure compliance with national and international standards and regulation.

• Ensure timely and efficient management of records pertaining to the Quality Assurance System, thru an effective and clear communication and escalation to ensure compliance in all Quality duties.

• Travel as reasonably requested by the Line Manager for the performance of duties.

• Assist in the maintenance of quality standards and work with other departments in continuous development and improvements.

• Undertake any other reasonable duties at the request of the line manager.

• Adhere to all company Policies and SOPs at all times.

Employee Type:
 

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