QC Analyst Incoming GoodsNetherlands - HoofddorpQualityRegular
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.
Kite, A Gilead Company
At Kite, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day – discoveries that include our own capabilities and our individual potential.
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 Team Lead.
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 support, coordinate and perform routine analysis of incoming goods
- To support, coordinate and perform daily receipt, inspection and release of patient apheresis
- To support, coordinate and perform sampling of incoming goods
- To support with the tech transfer of analytical methods if needed
- To write, perform, report and evaluate method transfers
- 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 act as a mentor to junior staff and train new employees
- To work with the team for troubleshooting issues and provide solutions
- To ensure an efficient process and meeting deadlines
- To write deviations, CAPAs and change controls
- To write, review and/or implement changes to controlled documents such as SOPs, Specifications, etc.
- To lead investigations and continuous improvement initiatives
- To support audits and regulatory inspections
- To perform other duties as required
Challenges of the Role
- To be able to work in a fast-paced environment
- To be able to thrive even under pressure
- To be pro-active
- To be able to work efficiently under minimal supervision
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 5 years 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
- Previous experience at performing tech transfers, writing protocols and reports
- Experience in performing and concluding investigations
- 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
- A positive and friendly can-do proactive attitude
- Hands-on, “roll up your sleeves” mentality
- Comfortable in a fast-paced environment with minimal direction
- Ability to adjust workload based upon changing priorities
- Ability to prioritize with strong time management skills
- Excellent communication skills
- Strong team player
- Working in day shifts (including weekends, early mornings and bank holidays)
- Work overtime as needed
As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together.
If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards eliminating the burden of chronic cancer care, don’t miss out on this opportunity to join us and discover your sense of purpose.
Only candidates in possession of a valid EU work permit will be considered.
Recruitment agencies: We seldom make use of agencies, and when we do, we have a PSL in place. We would appreciate if you did not contact hiring managers or the recruitment team directly, since we will not be able to respond to you.