Specialist, Document Control

The Role:
The Specialist role supporting Document Control and Records Management will be responsible for maintaining documents in compliance with business needs and regulatory expectations in addition to supporting process improvements in the document control and records management areas. The individual will be responsible for formatting and administration of paper-based and electronic document workflows as well as chain of custody, issuance, and archival of paper records. Excellent organizational skills, the ability to work independently on multiple tasks, and the ability to work in a fast-paced environment are required. This role will be 2nd shift (2pm – 12am), Wednesday-Saturday.

Here’s What You’ll Do:
Support cross functional teams in processing document requests, document approval, and document archival

Issuance and reconciliation of paper records (i.e., batch records, logbooks, protocols)

Manage the archival of all GMP documentation both on-site and off-site (organization and maintenance of the on-site archival room)

Develop and implement process improvements for Document Control and Records Management processes

Assist in document control process improvements including document types, lifecycles, and workflows in eDMS

Revise SOPs related to Document Control, Records Management

Collaborate with cross-functional teams to identify efficiencies around maintenance/control of paper-based documents

Provide document control/records management support for internal/external audits and inspections

Here’s What You’ll Bring to the Table:
BS degree with 3-5 years of Quality assurance experience in pharmaceutical industry providing Quality Assurance oversight OR 2 years of experience with MS degree

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 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!

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.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

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 United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com . (EEO/AAP Employer) #LI-KF1
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