Quality Assurance Associate

TN Germany; Kelsterbach; Vor Ort; EUR 45.000 - 60.000; Vollzeit

Zusammenfassung

A leading company in Kelsterbach is seeking a Quality Assurance Associate to support the CAPA System and Vendor Qualification process. The ideal candidate will have experience in Quality Management Systems and a degree in Pharmacy. Responsibilities include training, investigating deviations, and maintaining quality policies.

Qualifikationen

• At least 1 year of relevant experience in pharmaceutical/biotech industry.
• Experience with Quality Management Systems.

Aufgaben

• Support the CAPA System and Vendor Qualification process.
• Train vendors and employees on quality topics.
• Investigate deviations and develop action plans.

Kenntnisse

Attention to Detail

Interpersonal Skills

Conflict Mediation

Analytical Skills

Ausbildung

Degree in Pharmacy

Jobbeschreibung

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Quality Assurance Associate, Kelsterbach

Client:

Location:

Kelsterbach, Germany

Job Category:

Other

EU work permit required:

Yes

Job Reference:

653f3f8d6c75

Job Views:

1

Posted:

11.05.2025

Expiry Date:

25.06.2025

Job Description:

Description

Title: Quality Assurance Associate (m/f/d)

Job Purpose:

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

Main Duties and Responsibilities:

• Maintain the culture of the importance of an integrated quality system within the company.
• Train vendors and MKN employees on quality topics.
• Support the CAPA System.
• Investigate deviations and develop effective action plans.
• Complete CAPAs and conduct Effectiveness Checks.
• Support the Vendor Qualification process.
• Assist with the Document Control process.
• Maintain quality policies and procedures per company requirements.
• Evaluate and approve documents according to standards and regulations.
• Create and review instructions / SOPs.
• Collaborate with logistics to ensure operational effectiveness and compliance.
• Support quality audits and client qualification processes.

Requirements:

• Experience with Quality Management Systems and attention to detail.
• Knowledge of GxP.
• Good interpersonal skills, conflict mediation, and a sense of urgency.
• Ability to analyze details thoroughly.
• Ability to work remotely (home office).
• At least 1 year of relevant experience, preferably in pharmaceutical/biotech industry, including quality and logistics.
• Degree or recent graduation in Pharmacy or a related field.

Marken is a subsidiary of UPS, providing GMP-compliant depot and logistics services for clinical and commercial products, supporting cell and gene therapy logistics, and more.

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