Requirements: English
Company: Optimus Life Sciences
Region: Leiden , South Holland
Job Title : QC Document Specialist
Location : Leiden, The Netherlands
Contract Type : Freelance (6-Month Contract, Full-Time, Onsite)
Language: English
We are currently seeking a QC Document Specialist for a 6-month freelance assignment based in Leiden. This role supports Quality Control operations in a dynamic biopharmaceutical setting, focusing on GMP documentation, sample coordination, and compliance activities.
Key Responsibilities
- Draft and manage GMP-related documentation (deviations, investigations, CAPAs, change controls).
- Support environmental monitoring activities and related GMP reporting.
- Coordinate QC sample inventory, shipment preparation, and outsourcing documentation.
- Participate in material release processes, including reviewing specifications.
- Train colleagues in QC documentation practices and assist with data analysis as required.
- Ensure timely and accurate documentation in alignment with QC guidelines and regulatory expectations.
Key Requirements
- HLO or BSc degree in Life Sciences, Biotechnology, or a related field.
- 13 years of QC experience in the pharmaceutical or biotech industry.
- Working knowledge of GMP or GLP quality systems.
- Experience with documentation related to IOPQ, QIR, CAPA, or related QC processes.
- Familiarity with environmental monitoring or microbiology is a plus.
- Hands-on experience with assays such as ELISA, qPCR, potency/infectivity assays, or Western Blot preferred.
- Strong attention to detail, organizational skills, and ability to work independently in a regulated environment.
This is a freelance contract role based fully onsite in Leiden, The Netherlands. If you are an experienced QC professional with a passion for quality documentation and compliance, we encourage you to apply.
To apply , please send your CV to
Start Date : ASAP