What are the responsibilities and job description for the Specialist, Quality Control, Digital Support position at Moderna?
The Role:
Moderna is seeking a Specialist Quality Control, Digital Support based at their Norwood, MA campus. The individual in this role will focus on supporting all Digital laboratory systems. The individual will coordinate across QC and Digital teams to meet business objectives as well as assist in configuration and deployment of Digital systems in QC as needed.
Here’s What You’ll Do:
As part of the QC Digital team, your primary responsibilities will be as follows:
Provide tier 1 Digital support to the QC labs for the laboratory computer systems
Support Digital group with installs, configuration, and maintaining standalone laboratory systems
Serve as point person between Digital and QC
Manage and own quality systems records such as deviations, change controls, CAPAs from start to finish as it relates to system software in Quality Control
Support efforts for method troubleshooting, remediation, change and optimization efforts in cross functional teams as it relates to Digital Systems
Author/Revise Equipment, Software, and Method SOPs
Train QC analysts on system software as needed
Support cross-functional process improvement projects
This position may manage direct reports
Here’s What You’ll Bring to the Table:
Minimum education required: Bachelor’s degree in Sciences and 5-8 years of industry experience in a cGMP laboratory setting
Demonstrated SME proficiency in one of Labvantage LIMS, Chromeleon, Softmax Pro, or any other Laboratory Software
Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations
Strong technical background in HPLC/ UHPLC / Karl Fischer / GC (etc.) Instrumentation/ Software, and method acquisition
Strong technical writing skills, oral communication and organizational skills
Ability to collaborate effectively in a dynamic, cross-functional matrix environment
Ability to efficiently prioritize and complete multiple projects/tasks in a fast-paced environment
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 winter shut down
- 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 person’s 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.
