We are seeking a detail-oriented Associate Specialist (m/f/d) External Laboratory QC to support the quality oversight of external and contract laboratories during a maternity leave cover period starting at 1st of March for 12 months.
This role is central to ensuring that analytical data generated externally meets internal quality standards, regulatory expectations, and cGMP requirements. You will act as a key interface between internal Quality teams and external laboratories, ensuring data integrity, investigation management, and consistent quality performance.
Main tasks:
- Primary QC contact for external and contract laboratories, ensuring clear communication, quality alignment, and compliance with cGMP requirements
- SME for external laboratory analytical testing and methods, providing technical oversight and guidance on laboratory practices
- Lead and manage external laboratory investigations, including OOS, OOT, invalid results, and atypical trends, through to compliant closure
- Review, assess, and trend externally generated analytical data in accordance with cGMP and ALCOA+ data integrity principles
- Monitor and evaluate external laboratory performance, including deviation trending, KPI tracking, and quality metrics
- Support audits, inspections, and regulatory interactions related to contract laboratories, representing QC as required
Profile:
- Degree or equivalent qualification in Life Sciences, Chemistry, Biotechnology, Pharmacy, or a related scientific discipline
- Experience working in a GMP-regulated pharmaceutical or biotechnology environment
- Strong hands-on experience with external or contract laboratory management and oversight
- Solid understanding of analytical testing (biological and/or chemical) performed by third-party laboratories
- Practical experience with deviation management, CAPA, and change control, particularly involving external partners
- Experience supporting batch release activities using externally generated QC data is highly desirable
- Experience with SAP and electronic Quality Management Systems
- Proficient in English and German
Our Benefits:
- Flexible working hours (37.5 hours/week) and an attractive company pension scheme
- Competitive salary package: 13 monthly salaries + holiday pay + target bonus
- 30 days holiday entitlement
- Hybrid working model (up to 50 % remote)
- Internal training and promotion opportunities
- International co-operations
- Training on the job
- Contributing your own ideas to the process design
- Insights into the development of medicinal products
- Corporate benefits and free car parking
- Working across borders (20 days per year)
- Paid Parental Time Off (PPTO)
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
People with severe disabilities and their equivalents will be given preference if they are equally qualified.
Required Skills:
Accountability, Accountability, Analytical Testing, Batch Releases, Biopharmaceuticals, Biopharmaceutics, Biotechnology, Chemical Analysis, Chemical Biology, Chemical Physics, Chemistry, Detail-Oriented, GMP Compliance, GMP Laboratory, Integrity Management, IS Audit, Laboratory Analysis, Laboratory Information Management System (LIMS), Nondestructive Testing (NDT), Pharmaceutical Biology, Quality Control Inspection, Quality Control Management, Quality Engineering, Quality Improvement Programs, Quality Process Development {+ 5 more}
Preferred Skills:
