CAM Bioceramics B.V. is the global number one manufacturer of choice for our partners who are looking for the highest quality and best service in the field of Orthobiologic Ceramics. We are working with the leading companies in the medical & dental (device) industries, start-ups with compelling business ideas and engaged universities. We co-op with our customers in the United States, Europe, Asia and in Emerging Markets. We will continue to seek and deploy technological and engineering advancements. If you’re passionate about your field, we have a wide array of positions available at our HQ in Leiden. The environment is innovative, energetic and full of opportunity. Our company thrives on a diverse workforce. Currently we are looking for a QC Officer.
As a QC Officer within a fast growing contract development and manufacturing organization you will be mainly responsible for timely and according to specifications efficiently perform analysis, process and input controls. Also, the support of the other departments in the field of all QC-related matters, and advising relevant stakeholders is part of your job. You will review incoming goods, documentation regarding product specifications, verifications, and validation. Besides this, you will contribute and promote quality awareness throughout the company. The QC Officer works closely with the other QC officer and in a team with QA Officers and the RA Specialist.
Main tasks and responsibilities:
- Timely, and according to specifications efficiently perform analysis, process and input controls;
- Support other departments in the field of all QC-related matters;
- Advising relevant stakeholders;
- Review incoming goods, documentation regarding products specifications, verifications, and validation;
- Maintain adequate inventories for tasks (i.e. reagents, glassware, standards etc);
- Executes the specific inspections on materials, equipment and construction/installation activities on site;
- Maintain current, complete, legible notebooks and laboratory records in compliance with good documentation practices and good laboratory practice;
- Issues the relevant Quality Records and, when necessary, write and send to Manager QA/QC/RA non-conformances reports;
- Support laboratory investigations for known lab errors and OOS results using Trackwise and/or other QC procedures;
- Support troubleshooting of testing equipment, methods and processes;
- Execute laboratory processes in compliance with GMPs, site and corporate policies, standard operating procedures (SOPs) and test methods;
- Immediately report deviations that have the potential to compromise product quality.
- Responsible for continuous improvements in laboratory processes;
- Develops policies, procedures and methods to check product, material, components and/or operational quality and improve same;
- Maintain the effectiveness of the position related processes of the Quality System.
Our ideal candidate has:
- A Bachelor degree in e.g. Chemistry or comparable level through experience;
- At least 5 years relevant (international) experience within Quality Control in a laboratory or production department (e.g. as a laboratory analyst or process engineer) preferably in a related field (medical devices, pharmacy);
- You are highly motivated, driven by results and quality and a team player;
- You acknowledge and assume responsibility for performance of your results, demonstrate ownership, keep commitments, and have a positive attitude in a changing environment;
- Experience in fast paced and detail oriented environment heavy with requirements for complete and accurate documentation. Understanding of good documentation practices;
- Ability to successfully multitask;
- Organized, with good communication skills, focus on quality and attention to detail;
- Careful planning to achieve accurate and timely results;
- Ability to define and manage own tasks and schedules;
- Team player, but resolute when needed, comfortable reporting to remote management;
- Comfortable making decisions within assigned authority, comfortable to escalate when needed;
- Good knowledge of Dutch and English (verbal and written);
- Experience in an ISO 13485 and /or a GMP environment is necessary.
If you think CAM Bioceramics B.V. may be a great fit for the next step in your career? Than please send us your motivational letter and resume via email@example.com with reference “QC Officer”. If you need more information about this position please contact our HR department via firstname.lastname@example.org.
Feel free to send us your motivation and resume