Quality Assurance Specialist (m/f/d)

LGC Limited; Berlin; Hybrid; EUR 52,000 - 76,000; Full time

Job summary

LGC Biosearch Technologies in Berlin is seeking a Quality Assurance Specialist (m/f/d) to help maintain and improve our Quality Management System in a regulated environment. You will drive deviations, CAPAs, change controls and ensure documentation is inspection-ready, collaborating with cross-functional teams on site.

The role requires a degree in science or related field, experience with ISO 9001/13485, and fluency in German and English.

Qualifications

• Hands-on QA experience in a regulated environment.
• Degree in Science, Quality, Engineering, Biotechnology, Chemistry or Life Sciences.
• Experience with CAPAs, deviations, non-conformances, audits and document control.
• Knowledge of ISO 9001 and ISO 13485.
• Fluency in German and English.
• Strong organisational skills and ability to manage multiple priorities.

Responsibilities

• Maintain and improve the Quality Management System (QMS) in line with ISO 9001 and internal requirements.
• Own quality events: deviations, non-conformances, CAPAs, and change controls.
• Ensure robust documentation and eQMS administration.
• Support internal and external audits from preparation to follow-up actions.
• Ensure training requirements and quality records remain accurate and up to date.
• Support supplier and customer quality activities and quality-related requests.
• Analyze quality metrics and trends and propose practical improvements.
• Collaborate with Operations, Quality Control, Supply Chain and Customer Service to embed quality in daily work.
• Contribute to continuous improvement initiatives and site Daily Management System.

Skills

German (native)

English (fluent)

Organisation

Independent work

Education

Science/Quality/Engineering/Biotechnology/Chemistry/Life Sciences degree

Tools

EtQ

IFS

MS Office

Job description

• Department: Quality Assurance and Regulatory Affairs

Company Description

With manufacturing sites across the US, UK, Germany and Denmark, LGC Biosearch Technologies has plans to continue growing. We deliver mission critical genomics to our diverse customer base in molecular diagnostics, pharma/biotech and agrigenomics. Our integrated portfolio of products, services and expertise supports our purpose of Science for a Safer World and we have embodied our mission by working with customers to enable research into life-altering treatment for disease and illness worldwide. We are currently seeking candidates who are up for the challenge of operating in a high-growth, purpose-driven organisation.

Job Description

Quality Assurance Specialist (m/f/d) - Berlin | Full-time | On-site ( with some flexibility)

As our Quality Assurance Specialist (m/f/d) in Berlin, you’ll have the opportunity to make a visible impact on how quality works day to day. You’ll help strengthen our Quality Management System, turn quality data into meaningful improvements and work closely with colleagues across the site to keep our processes effective, compliant and ready for what comes next.

It’s an opportunity to combine hands-on Quality Assurance with continuous improvement in an international, purpose-driven organisation, all contributing to our mission: Science for a Safer World.

What you’ll make happen

Working closely with our Quality Manager and teams across the Berlin site, you will:

• Help maintain and continuously improve our Quality Management System (QMS) in line with ISO 9001 and internal quality requirements.
• Take ownership of quality events including deviations, non-conformances, CAPAs and change controls, assessing actions, tracking effectiveness and helping ensure timely closure.
• Keep our documentation robust and inspection-ready through effective document control and eQMS administration.
• Support internal and external audits, from preparation and documentation through to follow-up actions.
• Help ensure training requirements and quality records remain accurate, compliant and up to date.
• Support supplier and customer quality activities, including quality agreements, supplier records and quality-related requests.
• Analyse quality metrics and trends, identify opportunities for improvement and recommend practical changes.
• Partner with colleagues across Operations, Quality Control, Supply Chain and Customer Service to embed quality into everyday ways of working.
• Contribute your Quality expertise to continuous improvement initiatives and our site Daily Management System.

Qualifications

What you’ll bring

You’ll bring hands-on Quality Assurance or Quality Systems experience from a regulated environment and the confidence to work independently while partnering effectively with different teams.

• A degree in Science, Quality, Engineering, Biotechnology, Chemistry, Life Sciences or a related field.
• Previous experience in Quality Assurance, Quality Systems or compliance, ideally within biotechnology, diagnostics, pharmaceuticals, medical devices or another regulated industry.
• Practical knowledge of Quality Management Systems and standards such as ISO 9001 and/or ISO 13485.
• Experience working with CAPAs, deviations, non-conformances, investigations, audits and document control.
• A continuous improvement mindset and the ability to turn quality data into practical recommendations.
• Confidence using electronic quality/document management systems and Microsoft Office.
• Strong organisation skills and the ability to manage multiple priorities independently.
• Native-level German and fluent English, both written and spoken.

Even better if you have

• Experience within a regulated manufacturing, laboratory, life sciences or biotechnology environment.
• Experience delivering training or supporting organisational change.
• Knowledge of root cause analysis and corrective action methodologies.
• Experience with electronic Quality Management Systems, ideally EtQ, and ERP systems such as IFS.

Additional Information

Additional information

Our values

• PASSION
• CURIOSITY
• INTEGRITY
• BRILLIANCE
• RESPECT

Equal opportunities

LGC strongly believes that every job applicant and employee should be valued for their talents regardless of age, disability, race, color, ethnic or national origin, sex, sexual orientation, gender reassignment, marital or civil partnership, pregnancy or parental, religion, or belief. Shortlisting, interviewing, and selection will always be carried out without regard to gender, sexual orientation, marital status, color, race, nationality, ethnic or national origins, religion or belief, age, or trade union membership.