Quality Control Technician

Il y a 5 mois


VillersleBouillet, Belgique Cryoport Systems Temps plein

Cryoport Systems is the life science industry’s most trusted provider of supply chain solutions for temperature-sensitive materials, serving biopharmaceutical, IVF and surrogacy and animal health organizations around the world. Cryoport Systems' proprietary Cryoport Express® shippers, Cryoportal® Logistics Management Platform, leading-edge Smartpak Condition Monitoring System and geo-sensing technology paired with unparalleled logistics expertise and 24/7/365 customer support, make Cryoport Systems the end-to-end temperature controlled supply chain partner that you can trust.

The QC Tech position provides laboratory support for Cryoport laboratories in Belgium. This individual will be focus on GMP testing and executing method validation under supervision and coordination of Method SME. Depending on the phase of the company, this individual will be participating in activities including but not limited to laboratory setup, documentation, laboratory maintenance.

PRIMARY RESPONSIBILITIES (include but are not limited to)
- Execute compendial and internal methods. Techniques include, but not limited to sterility, and microbial limits testing, endotoxin, cell count/viability, flow cytometry.
- Execute Environmental Monitoring testing.
- Execute laboratory work plan as per schedule developed with input from supervisor or senior team member.
- Execute laboratory cleaning schedule.
- Maintain high quality documentation in accordance with regulatory guidance and site/global SOPs documenting work as appropriate.
- Execute procedures or methods of moderate complexity with high quality.
- Able to participate in shipping of goods following guidelines and protocols.
- Able to identify quality/compliance gaps during lab work (OOS/OOT).
- Participate in training. Able to execute methods after training schedule.
- Assist in the execution of efficiency/compliance improvement projects with guidance.

COMPETENCIES & PERSONAL ATTRIBUTES
- Passion for, and alignment with, Cryoport’s mission.
- Positive, proactive attitude. Brings strong core values, quality, ethics, and integrity.
- A collaborative team player who embraces and champions the culture.
- Strong work ethic and ability to deliver results and meet commitments in a dynamic environment.
- Willingness to continually embrace personal and professional development. Passion for, and alignment with, Cryoport’s mission
- Ability to work in global teams, where direct supervisor may occur remotely.
- A change agent and strong collaborator who is not afraid of challenging status quo.
- Exceptional and dynamic communications skills with the ability to inspire and influence people at all levels, build consensus and commitment, and effectively drive change throughout the organization at a rate that fits the corporate culture.
- Exceptional organizational and planning skills, strong analytical abilities, and process orientation. Attention to detail, accuracy, and the ability to prioritize.
- Demonstrates a business process orientation to developing solutions.
- Basic understanding of instrument operations and troubleshooting skills in multiple techniques in Microbiology and Cell Therapy.
- Proficient with PC and Microsoft Software
- Strong written and verbal communication skills.
- Well organized and work effectively under pressure to meet deadlines.
- Individual may be required to sit, stand, walk regularly and occasionally lift 0-40 pounds;

QUALIFICATIONS AND EDUCATION REQUIREMENTS
- Fluent in French, B2 level in English as minimum required.
- Bachelor’s degree or higher; Biotechnology/Biomedical, a plus
- At least 1-2 years of experience in pharmaceutical industries, Cell therapy and/or blood bank. Previous QC experience and Environmental Monitoring Experience is a Plus.
- Ability to lift at least 25 lbs (12 Kg)


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