QC Analyst – QC Incoming Goods
Start: Preferably ASAP (realistically 1st of AUG)
As an analyst for QC Incoming Goods you will be responsible for ensuring that incoming raw materials are processed accurately and released in a timely manner including inspection and release of patient apheresis material.
We’re currently seeking to recruit highly motivated talents for different positions, to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer.
As an analyst for QC Incoming Goods, you will be joining a new team in which people of all backgrounds and experiences are respected, and where working together while being focused on saving lives by finding the cure for cancer is a daily activity.
The QC Incoming Goods group is part of the Quality Control department. The Quality Control department ensures consistent quality throughout the manufacturing process by providing accurate testing of incoming goods, in-process samples, final product and stability samples. The team is diverse, enthusiastic and hard working.
You will be reporting to the QC Incoming Goods Manager.
In this role, you will process incoming (raw) materials including patient apheresis while ensuring total cGMP compliance. Due to the nature of the treatment, this role requires a high level of proficiency, ownership of the process and a strong sense of responsibility.
Your responsibilities, among others, will be:
- To perform routine analysis of incoming goods
- To perform daily receipt, inspection and release of patient apheresis
- To perform sampling of incoming goods
- To follow strict cGMP rules to ensure quality
- To maintain a 5S lab
- To interact and coordinate with multiple departments in a professional and friendly manner
- To coordinate with external suppliers
- To work with the team for troubleshooting issues and provide solutions
- To ensure an efficient process and meeting deadlines
- To support or write deviations, CAPAs and change controls
- To write changes to controlled documents such as SOPs, Specifications, etc
- To support investigations and continuous improvement initiatives
- To support audits and regulatory inspections
The ideal candidate has a can-do attitude and thrives in a fast-paced environment. Because the QC Incoming Goods group is involved with multiple departments, a strong ability to communicate and coordinate is essential to ensure a smooth and efficient process. The ideal candidate should possess a technical mind but also be able to think outside the box in order to use logic and sound judgement to provide solutions to problems.
- A BSc degree and minimum 2 year of experience in the Biotech and/or Pharmaceutical Industry
- Full working knowledge of GMPs, GLPs, pharmacopoeia and regulatory requirements
- Proficient in application of QC principles, concepts, industry best practices and standards
- Organization and prioritization skills
- Strong interpersonal skills and willingness for team work
- Previous hands-on experience in a QC lab capacity
- Proficiency in quality control systems, methods and procedures for routine and non-routine analysis of raw materials
- Knowledge of HPLC, FT-IR, ELISA and WB.
- Experience in writing and implementing deviations, change controls and CAPAs
- Experience in writing or updating SOPs and analytical methods
- Strong verbal and technical writing skills in English