Specialist, Quality Control Technical Support
- Employer
- Moderna, Inc.
- Location
- Norwood, MA
- Start date
- Jan 16, 2023
View more
- Discipline
- Clinical, Clinical Documentation, Quality
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Genetown, Best Places to Work
Job Details
The Role
In this role, you will support QC Labs with review of test records and manage QC Quality records (e.g. Change Controls, deviations, CAPA, Lab investigations, etc.) as well as author/update cGMP documents.
Heres What Youll Do
Review executed QC test records for product release, including the investigation and resolution of deviations, OOS and OOT observations.
Work with QC group to maintain and update all necessary training documentation including; On-The-Job Trainings, Training Materials, Instructor Led Training, and Knowledge Checks.
Supports authoring and revision of laboratory procedures and reports
Support authoring quality systems records such as deviations, change controls, CAPAs as required
Supports team to Investigate and resolve issues related to assay failures, system deficiencies, deviations, and equipment / assay troubleshooting.
Lead projects as assigned
Additional duties may be assigned
Heres What Youll Need (Minimum Qualifications)
BA or BS degree in Biology, Microbiology or similar field
5+ years of direct experience in pharmaceutical QC Microbiology with experience in different Microbiological Assays such as Endotoxin, Sterility, Bioburden, Growth Promotion, Microbial Identification and environmental monitoring. TOC, pH and conductivity experience desired.
Previous experience reviewing data for GDP/GMP compliance as well as audit trail review
Previous experience managing quality records such as change controls, deviations, and lab investigations
Heres What Youll Bring to the Table (Preferred Qualifications)
In depth understanding of compendial microbiology testing and techniques per USP, EP and JP requirements
Experience with rapid microbiological methods
Expertise in aseptic technique training and concepts
Experience with performing laboratory and deviation investigations
Experience in Technical writing and SOPs
Proficiency with Microsoft Office Programs
Familiarity with electronic databases (e.g. LIMS, SAP, LMS, MODA)
Demonstrated ability to work effectively under established guidelines and instructions
Ability to collaborate effectively in a dynamic, cross-functional matrix environment
Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations
Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment
Excellent communication skills (verbal and written)
A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- Highly competitive and inclusive medical, dental and vision coverage options
- Flexible Spending Accounts for medical expenses and dependent care expenses
- Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
- Family care benefits, including subsidized back-up care options and on-demand tutoring
- Free premium access to fitness, nutrition, and mindfulness classes
- Exclusive preferred pricing on Peloton fitness equipment
- Adoption and family-planning benefits
- Dedicated care coordination support for our LGBTQ+ community
- Generous paid time off, including:
Vacation, sick time and holidays
Volunteer time to participate within your community
Discretionary year-end shutdown
Paid sabbatical after 5 years; every 3 years thereafter - Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
- 401k match and Financial Planning tools
- Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
- Complimentary concierge service including home services research, travel booking, and entertainment requests
- Free parking or subsidized commuter passes
- Location-specific perks and extras!
Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.
About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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Company
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. Moderna’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.
mRNA is now a turning point in the history of science, medicine, technology, even humankind itself. With this breakthrough discovery, many of the world’s biggest and most challenging medical problems are no longer a question of “how?” but merely a question of “when?”
Come with us as we pursue the uncharted reaches of possibility and make your mark on the future of medicine.
Stock Symbol:
MRNA
Stock Exchange:
USNASDAQ GS
- Website
- https://modernatx.com/
- Phone
- 617-714-6500
- Location
-
200 Technology Square
Cambridge, MA
United States
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