Qc Doc Control, Associate Ii - Quality Control

The Role
In this role, you will be a part of the QC Compliance Document Control team, working closely with the QC laboratories to assist with inventory and reconciliation of testing and other QC documentation. This role will be integral in maintaining proper handling of cGMP QC controlled documentation working with both the labs and QA Document Control teams.
Here’s What You’ll Do
Ensure adequate inventory of QA-controlled laboratory testing documentation is available to the Moderna Norwood QC laboratories on a routine daily basis.
Request controlled QC testing documentation from QA Document Control, as needed.
Deliver, file and organize test documentation to the various QC laboratories.
Scan completed lab testing documentation with a high level of accuracy per Moderna’s true copy procedures and upload to the electronic document management system.
Perform document certification review of completed testing packages and other QC documentation per the true copy procedures.
Work collaboratively with laboratory personnel to reconcile incomplete or erroneous testing or other QC documentation, as needed.
Reconcile and archive completed testing documentation packages and other QC documentation to QA Document Control.
Ship QC controlled documentation between Moderna buildings or sites, as needed.
Record QC document control activities performed in required logbooks per GMP standards.
Perform other activities or special projects related to QC Document Control as assigned periodically.
Perform all activities with adherence to GMP requirements.
Maintain on-time QC and cGMP training compliance.
Here’s What You’ll Need (Minimum Qualifications)
BA/BS or Associated degree in a relevant scientific discipline, or 5 years related experience in a cGMP organization.
Here’s What You’ll Bring to the Table (Preferred Qualifications)
Familiarity with relevant and current FDA, EU and ICH guidelines and regulations
Knowledge of cGMP, good documentation practices and general laboratory safety
General knowledge of quality control laboratory operations
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:

• Paid sabbatical after 5 years; every 3 years thereafter
• Volunteer time to participate within your community
• Vacation, sick time and holidays
• D iscretionary year-end shutdown

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.
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