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Analyst, Quality Control
2 weeks ago
**The Role**:
Reporting to the Associate Director of Quality Control, the Microbiology & Bioassay Quality Control Analyst, will perform Quality Control testing using Bioassay and Microbiology various testing techniques in a GMP testing environment for mRNA products produced at Moderna’s manufacturing facility and affiliated contract organizations:
Microbiological method, including Bioburden, Sterility, BET, Micro sequencing, others
Molecular Biology methods, focusing on molecular and protein analytics such as: Agarose Gel Electrophoresis, UV/Vis measurement, Sanger Sequencing, protein concentration determination and qPCR, ELISA, Cell-Based Potency testing, and other methodologies as needed.
routine testing for cGMP QC raw materials, excipients, drug substance and finished product,
This position will contribute to related method transfers and qualification activities; The QC Analyst may also perform projects as assigned.
**Here’s What You’ll Do**:
Execute GMP QC Molecular Biology methods, focusing on molecular and protein analytics, but also supporting ELISA, Cell-Based Potency testing, and other methodologies as needed.
Execute GMP QC Microbiology methods, focusing on Sterility testing, Bioburden Analysis, Endotoxin, Micro sequencing in addition to other general methods such as TOC and Conductivity testing and other methodologies as needed.
Support testing for drug substances and drug products, including generation of testing data to support other studies as needed.
Conduct analysis related to Bioassay and Microbiology laboratory such as: TOC, Conductivity, Bioburden, Sterility, and Endotoxin, Identification by Sanger Sequencing, qPCR methods execution, ELISA, Cell-Based Potency testing and others.
Perform routine environmental monitoring and critical utility sampling activities, if required
Collaborate with AS&T groups on new methods transfers. Participated in method transfer projects for internal and external testing labs.
Assist in development, implementation, and maintenance of general laboratory operational systems in accordance with cGMP requirements
Provide support to audit teams for internal and vendor audits
Prepare and ship/receive contract laboratory testing samples including those intended for microbiological identification
Perform general laboratory support activities including reagent preparation, equipment maintenance and housekeeping
May participate in equipment and method qualifications, validations, and method transfers
Perform data entry utilizing good documentation practices
May assist with troubleshooting assay methods and equipment. Supports more junior staff with data review, training, and troubleshooting.
Participate in authoring quality systems records such as investigation, deviations, change controls, CAPAs; Write/revise SOPs, protocols, and reports.
**Here’s What You’ll Bring to the Table**:
BSc/BA in a relevant scientific discipline with 5 years Quality Control experience in a cGMP organization with a focus in Molecular Biology, DNA Sequencing and Microbiology.
Hands on experience with molecular biology techniques including, but not limited to, gel electrophoresis, qPCR, and Sanger Sequencing.
Hands-on experience of various Microbiology testing techniques and analyses (e.g. Vitek, Isolator Technology, Bioburden, BET, Sterility, others)
Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations preferred.
Working experience in a GMP environment.
Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.
Proven ability to conduct investigations.
Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.
We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
Educational resources
Savings and investments
Location-specific perks and extras
The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a c
