Data Review, Quality Control Bioassay - Norwood, United States - Moderna

Moderna

Verified Company

Norwood, United States

2 days ago

Posted by:

Mark Lane

beBee recruiter

Description

The Role

In this role, the QC Bioassay Data Reviewer will support data and records review in LIMS, Veeva, and assay worksheets.

Additionally, this role is responsible for review of department logbooks.

Here's What You'll Do

Review executed QC test records (paper and electronic records)

Review audit trails

Review reagent and equipment logbooks

Record and report out metrics on right first time execution

Lead and organize continuous improvement projects

Write/revise SOPs

Assist with audit preparation and regulatory compliance

Additional duties may be assigned

Here's What You'll Need (Minimum Qualifications)

BA or BS degree in Biochemistry or relevant scientific discipline

5+ years of direct experience in Molecular Biology and Cell Based Assays (e.g. qPCR, sequencing, potency, mammalian, and bacterial cell culture)

Previous experience reviewing/approving data in GMP environment for GDP/GMP compliance as well as audit trail review

Ability to pay attention to details and follow procedures

Here's What You'll Bring to the Table (Preferred Qualifications)

Experience with performing lab investigations (OOS)

Experience with change controls

Experience with Word, Excel, PowerPoint, and Smart Sheet

Prior Training experience (i.e. on the job training)

Ability to efficiently prioritize, manage and complete multiple projects and tasks in a fast-paced environment

Excellent communication skills (verbal and written)

Working knowledge of USP, ISO, FDA and ICH guidelines

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
D iscretionary yearend 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

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 culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship.

Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.

Moderna is an E-Verify Employer in the U