Specialist, MS&T – Investigations

The Role

In this role, you will exercise with limited supervision, discretion and applies knowledge of cGMP regulations and biopharmaceutical production processes to oversee the execution of thorough investigation and root cause analyses of quality events to ensure corrective and preventative actions are identified. Intermittently, work will be conducted within a cleanroom environment and typically involves limited physical activity, lifting and standing for periods of time.

Here’s What You’ll Do

• Follow all relevant GMP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
• Practice and promote safe work habits and adheres to safety procedures and guidelines.
• Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
• Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
• Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence of gowning and vision, if applicable.
• Utilize the manufacturing support systems and equipment as required including, but not limited to, SAP, VEEVA, Delta V, Syncade, LIMS.
• Utilize manufacturing process knowledge and investigational skills applying techniques such as Fishbone/Ishikawa analysis, 5-Why, Kepner Tregoe, to identify and resolve manufacturing issues, deviations, non-conformances, and unexpected events.
• Lead cross functional teams to drive complex investigation close outs, determine root causes and implement appropriate corrective and preventive actions (CAPA)
• Conduct document revisions and/or document management including batch production records and manufacturing procedures.
• Generate investigative test plans and reports, as required.
• No approval or delegation authority associated with this role.
• Additional duties as may be assigned from time to time.
  
  
  

Here’s What You’ll Need (Basic Qualifications)

• STEM degree with 3-5 years’ industry experience or a Masters’ degree with 1-2 years’ industry experience
  
  
  

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

• 0-2 years’ experience with deviation/investigation management systems or a similar technical writing system in a cGMP environment. Comprehensive understanding of GMP regulations.
• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
  
  
  

Moderna provides employees with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental, and vision coverage options
• Dedicated guided healthcare coordination through Included Health that elevates healthcare planning for every kind of employee, including our LGBTQ+ employees and other underserved communities
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account to help you engage in personal enrichment and self-care activities
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• Family care benefits, including subsidized backup care options and on-demand tutoring
• Adoption, surrogacy, and family-planning benefits
• Paid time off, including:
• Vacation, sick time, and observed Company-wide holidays
• Paid volunteer time to participate within your community
• Discretionary year-end shut down
• Paid 4-week sabbatical after 5 years, and every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• Generous 401k match and Financial Planning supports
• Moderna-paid Life, LTD, and STD insurance, as well as voluntary benefit options
• Concierge service including home services research, travel booking, and entertainment requests
• Free premium access to fitness, nutrition, and mindfulness classes including exclusive preferred pricing on Peloton fitness equipment
• Free parking, subsidized parking, or subsidized commuter passes, depending on location
• Location-specific perks and extras!
  
  
  

Notices

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)

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!
  
  
  

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.

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 contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

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