Quality Assurance Specialist (Full-/Part-time) (all genders)

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

BioReliance® Contract Testing Services offer exceptional, risk-mitigating solutions with technical and regulatory expertise, to help bring life-changing drugs to market. Our testing and manufacturing services span the product cycle from early pre-clinical development to licensed production. Clients partner with us to meet their needs for biologics safety testing, analytical development, and biomanufacturing services.

Our work is governed by stringent GMP standards, and we are looking for driven professionals to join us on this exciting journey.

Scope of Responsibility

Responsibilities

Quality is the foundation of our business. The Quality Assurance Specialist promotes and integrates quality into every aspect of our operations. Core responsibilities include:

• Development and maintenance of the Quality Management System (QMS) during new site build-up.
• Ensuring full compliance with sound scientific practice, GMP, and standard operating procedures.
• Meeting individual and company quality goals and objectives.
• Acting as a key user and driver for electronic systems, including SAP, LIMS, and the Document Management System (DMS).

Purpose of the Position

The Quality Assurance Specialist reports to the Head of Quality. The role holder will carry out assigned tasks with competence and undertake any other reasonable duties assigned by QA Management.

The primary focus of this position is to conduct quality activities by supporting Operations areas, ensuring compliance with the QMS, GMP regulatory standards, relevant SOPs, and customer specifications. This includes a strong emphasis on document management, deviation handling, data audit, and QC raw material release.

Essential Job Functions

The operational activities will include (but are not limited to):

Document Management & Electronic Systems

• Act as key user for the Document Management System (DMS), SAP, and LIMS during new site set-up and ongoing operations.
• Perform review and approval of GMP documents, including protocols, technical specifications, batch records, logbooks, SOPs, validation protocols, and other QMS documentation.
• Support the operating and maintenance of systems required for core site QMS activities.

Deviation & CAPA Management

• Review and close deviations (Events), change controls, CAPAs, and effectiveness checks.
• Interact with other departments to ensure compliance with internal procedures and timely closure of quality events.

Data Audit

• Perform data audit and approval of completed testing documentation, ensuring compliance with applicable regulatory standards, approved TS, protocols, and SOPs.
• Ensure GMP data integrity principles are adhered to across all electronic and paper-based records.

QC Raw Material Release

• Perform or support QC material release activities, including review of raw material testing results and documentation.
• Support quality business functions such as quality control, archiving, and document control.

Cross-functional Support

• Support in internal audits as required.
• Support the supplier auditing program and client audits as required.
• Participate in projects as assigned.
• Ensure all duties are carried out according to GMP principles.

Who Your Are

• Bachelor’s Degree or equivalent in Biological Sciences, Chemistry, Pharmacy, Quality Management, or a related field.
• At least 2 years of experience working within a laboratory or analytical environment.
• Previous experience in a quality-driven or GxP-regulated environment (GLP/GMP).
• Hands-on experience with electronic quality systems – SAP, LIMS, and/or Document Management Systems is mandatory.
• Proficient in electronic systems relevant to GMP environments (SAP, LIMS, DMS/eDMS).
• Highly motivated self-starter with the ability to work independently and take initiative.
• Strong ability to plan and organize workload to meet or exceed all deadlines.
• Excellent attention to detail – essential in a regulated environment.
• Ability to work effectively in a fast-paced, evolving environment typical of a new site build-up.
• Good oral and written communication skills in German and English.
• Demonstrated adaptability and flexibility.

What we offer:

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!