QC Specialist (Microbial testing)
Our passion for science and technology is what drives our more than 64,000 employees across 66 countries to find solutions to some of today’s toughest challenges and create more sustainable ways to live.
Work Your Magic with us! Start your next chapter and join MilliporeSigma.
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
QC Specialist (Microbial testing)
Your Role:
- Participate in routine Microbial testing of raw materials and finished products using various testing techniques. (i.e. Microbial limit, Sterility, Endotoxin, Bioburden, Cell based growth promotion test, Cytotoxicity, MTT, Cell-line management, AVA, Mycoplasma, others etc.)
- HVAC Environmental Monitoring and Water, Gas quality manage (EM, PW/WFI/PS, N2/CA)
- Establish QC systems, procedures, and other required analytical documents e.g. specifications, methods, logbooks in the new facility to ensure that Micro-lab operations comply with company standards and customer expectations.
- Working in QC lab according to ISO 9001, 45001, 14001, EXCiPACT and EHS guideline in Korea.
- Participate in qualification of QC equipment, clean room, and clean utilities; analytical method validation, computerized system validation of QC systems. Support cleaning validation and process validation.
- Closely work with project team to design and establish QC labs in the new facility. Ensure operational readiness of QC labs to support project qualification, validation activities.
- Proper maintenance and troubleshooting of measurement system
- Support tech transfer of products from giving sites and ensure equivalent quality.
- Revise, review and write new SOP’s or update existing procedures
- Perform and participate in out-of-specification and deviation investigations
- Collaborate with global site SMEs on relevant subjects.
Who you are:
- Minimum bachelor's degree in pharmaceutical sciences, life sciences, biology, microbiology, or a related discipline
- 5+ years QC in the pharmaceutical, biotechnology or medical device
- Additional experience in animal cell management (e.g., CHO, BHK, MDBK) or GMP laboratory experience in animal cell–related testing is preferred
- Good global communication skills and a collaborative global team mindset.
- Good decision-making and problem-solving capability.
- Experience in managing microbiological tests
- Fluent in English
The company reserves the right to withdraw the offer, it if discovers subsequently that a candidate has given false information in application or has provided false or fraudulent documentation in support of his/her application.
If there is a possibility of legal issues arising against the company (머크) due to a candidate's responsible actions, such as the infringement of trade secrets of their current employer, the company may cancel the hiring even after the candidate has been employed.
