Specialist, Quality Control, Data Reviewer
- Employer
- Moderna, Inc.
- Location
- Norwood, MA
- Start date
- Feb 3, 2023
View more
- Discipline
- Clinical, Clinical Medicine, Quality
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Genetown, Best Places to Work
Job Details
The Role
Moderna is seeking a data reviewer at Specialist level for Quality Control Chemistry laboratory. The individual in this role will focus on Release, Stability and In Process data review and reporting for clinical and commercial products. This role may support protocol testing data review and special projects as needed. This role will be working the third shift (10pm-8am) Sunday through Wednesday.
Heres What Youll Do
Performs routine analytical chemistry data review for the data generated through the laboratory tests including HPLC, UPLC, GC, UV, Particle Analysis and Dynamic Light Scattering, Spectramax Plate Reader, Osmolality, pH, KF, appearance, etc.
Perform data review in LIMS and/or in paper worksheets to meet the project timeline.
Ensure all laboratory tests are performed correctly and meet cGMP and GDP compliance requirements.
Ensure stability data review completed within the required timeline.
Actively support OOS, OOT, OOE and LE investigations and be able to write investigation reports.
Participate quality event investigations such as deviations, change controls, CAPAs, effectiveness check author the related documents, coordinate with QA, and follow through the event closure as needed
Ensure laboratory data integrity comply with US and international regulatory requirements
Interact with other analysts when corrections are identified as part of the data review process.
Supports troubleshooting of methods and equipment.
Performs data entry and supports trending and regulatory submission as applicable.
Support Certificate of Analysis generation as needed.
Participates in project meetings to provide status updates to stakeholders
Provides prompt communication of risk and mitigation for all data management related deliverables.
Assist in regulatory, customer and internal quality audits that involve data review and data management.
Assist in test scheduling as necessary (e.g., when tests needs to be repeated based on data review) to meet the project timelines.
Work on identifying procedure gaps, continuous improvement for data review requirements and processes to ensure delivery of highest quality of data
Provide appropriate SME training for the department
Maintain and manage cGMP documentation (electronic and Hard Copy) for laboratory raw data packets.
Write/revise SOPs, protocols and reports if applicable
Establish and maintain a safe working environment
Additional duties as may be assigned from time to time
Heres What Youll Need (Minimum Qualifications)
Minimum education required: Bachelors degree in a relevant scientific discipline, preferred in Analytical Chemistry, or Chemistry
Minimum experience required: 5 years in a laboratory setting with focus in analytical chemistry
Heres What Youll Bring to the Table (Preferred Qualifications)
Have in-depth understanding of the clinical and commercial product life cycle process and the corresponding cGMP pharmaceutical data management and regulatory cGMP/GDP compliance
Solid scientific and technical breadth to support analytical test methods used in a biopharmaceutical manufacturing facility
Strong mathematical skills, including the ability to analyze scientific and test data, and solid understanding of statistical analysis
Have in-depth knowledge of analytical chemistry related to the SOPs and testing methods, especially for chromatographic separations using UPLC/HPLC./GC. Be able to provide in-depth training of proper chromatographic integration to lab analysts.
Strong chromatographic (LC/GC) experiences and troubleshooting skills
In-depth knowledge and expertise in method transfers/qualifications/validations
Solid knowledge on cGMP, USP/EP/JP compendia testing requirements
Strong communication skills as well as organizational skills
Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment while maintaining good quality
Details and results oriented
Solid technical writing and data interpretation skills.
Outstanding ability to multi-task
Highly independent and self-motivated
Strong sense of urgency
Ability working under pressure while maintain high quality
Ownership to the projects and commitment to meet the timelines
Solid knowledge of lab safety
Highly proficient use of Microsoft Word and Excel, Chromatographic Software
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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