QA Specialist

PROLYTIC

PROLYTIC ist ein wissenschaftlich-technisches Dienstleistungsunternehmen, das sich an biotechnologische und pharmazeutische Unternehmen richtet. Wir bieten ein breites Spektrum an analytischen Dienstleistungen in den Bereichen Bioanalytik, Pharmakokinetik, Pharmazeutische Analytik und RNA/DNA-Analytik, von der präklinischen und klinischen Entwicklung bis zur Vermarktung von verschiedenen Arzneistoffen an.

Stellenbeschreibung

Prolytic GmbH | Part of the Kymos Group

About Prolytic / Kymos Group

Prolytic GmbH is a specialized GLP-certified bioanalytical laboratory and has been part of the Kymos Group since 2020. The Kymos Group is a leading international CRO providing analytical and bioanalytical services to support drug development from preclinical stages to market authorization.

To strengthen our Quality Assurance team, we are looking for a motivated QA Specialist (m/f/d) to join us at the earliest possible date.

Your Responsibilities

• Maintenance and continuous improvement of the GLP quality system
• QA review and approval of study plans, raw data, and final study reports
• Handling of deviations, OOS/OOT investigations, and follow-up of CAPAs
• Preparation, review, and maintenance of SOPs and quality-relevant documentation
• Planning, conduct, and follow-up of internal audits and of customer and regulatory inspections
• Training of staff in GLP and QA-related topics
• Close collaboration with bioanalytical departments and the QA teams within the Kymos Group

We Offer

• A responsible and varied position in an established GLP-certified bioanalytical laboratory
• Integration into an international CRO group with development and career opportunities
• Opportunity to work on innovative drug development programs for international biotech and pharma clients
• Flat hierarchies and short decision-making processes
• A collaborative and scientifically driven working environment
• Flexible Working hours / flextime
• Good accessibility by car and public transportation
• Free drinks (coffee, tea, water)
• Company medical care
• Competitive salary and benefits package

Interested?
We look forward to receiving your application and getting to know you.

Anforderungen

Your Profile

• University degree in a life science discipline (e.g. Biology, Chemistry, Biochemistry) or a comparable qualification
• Professional experience in Quality Assurance within GLP and sound knowledge of GLP regulations
• Knowledge of GMP-regulations desirable
• Structured, detail-oriented, and independent working style
• Strong communication skills and a collaborative mindset
• Very good command of German and English