Scientist - QC Reviewer - Immunochemistry
Thermo Fisher ScientificSalary not specified
Not SpecifiedCompensation
Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, PharmaceuticalsIndustries
Requirements
- Bachelor’s, Master’s, or Ph.D. in Biology, Biochemistry, Microbiology, Biotechnology, Analytical Chemistry, or a related field
- Quality Control (QC) Testing experience in a GMP-regulated environment
- In vitro assay development and validation (ELISA, cell-based assays, endotoxin testing, etc.)
- Hands-on experience with Monocyte Activation Test (MAT) and alternative pyrogen testing methods
- Proficiency in using analytical instruments (HPLC, PCR, spectrophotometry, flow cytometry)
- Knowledge of sterility testing, bioburden analysis, and endotoxin detection (LAL, rFC assays)
- Experience with method validation, qualification, and troubleshooting of bioassays
- Strong problem-solving and troubleshooting abilities
- Attention to detail and excellent documentation skills (writing protocols, reports, SOPs)
- Ability to handle multiple projects and meet tight deadlines in a fast-paced environment
- Experience with risk assessments, CAPAs, deviation investigations in QC
- Understanding of pharmacopoeial requirements (USP, EP) for pyrogen testing
Responsibilities
- Implement and monitor quality control standards to ensure production excellence
- Optimize manufacturing processes to increase efficiency and quality
- Uphold stringent quality assurance standards to meet internal and regulatory requirements
- Conduct regular audits and reviews to ensure compliance with industry standards (e.g., ISO9001, GMP)
- Maintain meticulous records of all quality tests and results
- Analyze data from production and QC tests to identify trends and areas for improvement
- Lead and train team members to ensure high performance and adherence to quality standards
- Develop training materials and protocols for quality control procedures
- Oversee and execute product testing methods to validate the quality of products
- Implement new testing techniques and technologies to enhance product reliability
- Collaborate with R&D and production teams to integrate quality control measures throughout the manufacturing process
- Prepare detailed reports on quality control outcomes, challenges, and process improvements
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What is the salary for the Quality Control Scientist position?
This information is not specified in the job description.
Is this a remote position, or is there a required location?
This information is not specified in the job description.
What skills and experience are required for this role?
Required qualifications include a Bachelor’s, Master’s, or Ph.D. in Biology, Biochemistry, Microbiology, Biotechnology, Analytical Chemistry, or related field; QC testing experience in a GMP-regulated environment; in vitro assay development and validation (ELISA, cell-based assays, endotoxin testing); hands-on experience with Monocyte Activation Test (MAT) and alternative pyrogen testing; proficiency with analytical instruments (HPLC, PCR, spectrophotometry, flow cytometry); and knowledge of sterility testing, bioburden analysis, and endotoxin detection.
What is the company culture like at MAT Research?
MAT Research is committed to ethical and accurate diagnostics through animal-free testing like the Monocyte Activation Test (MAT), upholding the highest quality standards as an ISO:9001:2015 certified company, and supporting the replacement of animal-based tests to increase patient safety and save animal lives.
What makes a strong candidate for the QC Scientist role?
Strong candidates will have advanced degrees in relevant scientific fields, hands-on GMP QC experience, expertise in in vitro assays including MAT and pyrogen testing, proficiency with analytical instruments, and skills in method validation, team leadership, and data analysis.
Lam Research
About Lam Research
N/AHeadquarters
N/AYear Founded
N/ACompany Stage
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