Sr. Specialist, Quality Assurance
3 weeks ago
The Role
In this role, you will support clinical drug product (DP) (aseptic fill finish) manufacturing at Modernas Norwood manufacturing facility. The incumbent will support all operational aspects of clinical DP QA. This includes batch record review and disposition, quality oversight of manufacturing activities, deviation management, change management, sterility assurance support, and continuous process improvement.
Moderna has a diverse and expanding pipeline. At the Norwood site, we have invested in multiple aseptic manufacturing technologies including vial, prefilled syringe, and lyophilization. Our operations require an innovative approach to quality management to enable our continued leadership in developing mRNA medicines.
This position is on our Wednesday Saturday 2nd Shift (2pm 12am).
Heres What Youll Do
Within 3 months
- Complete all required quality and safety training and qualification.
- Participate in Tiered and other operational/quality toolbox meetings.
- Ensure adherence to all environmental, health, and safety guidelines, promoting a culture of safety within the DP organization.
- Perform on the floor oversight of manufacturing processes including, aseptic filling, visual inspection and label and pack.
- Provide technical support of cGMP manufacturing, including review and approval of technology transfer documents, change controls, and manufacturing investigations.
- Routinely identify and escalate quality risks, and proposed resolution through governance channels, where needed.
- Work to ensure a Right-First Time and mature quality culture is developed and maintained within the DP organization.
- Ensure timely resolution and/or escalation of quality issues to senior management.
- Collaborate with Manufacturing Operations, Technical Development, and MS&T for monitoring process performance and improving process consistency.
- Support the development of key performance indicators (KPIs) to measure and report on operational and quality performance.
- Drive and/or support continuous improvement initiatives to enhance operational efficiency, reduce costs, and improve product quality. Specifically, participate in the execution of the Site Quality Plan.
- Collaborate with cross-functional teams working in a highly matrixed environment to drive quality decisions and influence outcomes to enable Modernas clinical pipeline.
- Support quality and operational readiness plans for the start up of a new aseptic fill/finish facility.
- Lead or participate in cross functional teams to improve business practices and drive operational efficiency and effectiveness.
- Science or Engineering background (B.S.) with 5+ years of experience or MS with 3+ years of experience in a pharmaceutical or biotechnology company.
- Experienced in aseptic manufacturing operations. Demonstrated experience in quality and technical support of aseptic processes.
- Knowledgeable in problem solving, investigations and root cause analysis.
- Experience in leading and/or supporting tech transfers, change controls and investigations.
- Excellent communication skills (verbal and written).
- Ability to manage projects in a fast-paced, dynamic environment.
- Ability to effectively collaborate in a dynamic, cross-functional matrix environment.
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
- 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, theinfrastructure 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 peopleare 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. Were 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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norwood, United States Randstad US Full timespecialist, quality assurance. + norwood , massachusetts + posted 3 days ago **job details** summary + $40 - $50.97 per hour + contract + bachelor degree + category life, physical, and social science occupations + reference48123 job details job summary: As the largest staffing and recruitment agency in the world, we can commit to finding you...
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norwood, United States Randstad US Full timespecialist, quality assurance. + norwood , massachusetts + posted 3 days ago **job details** summary + $40 - $50.97 per hour + contract + bachelor degree + category life, physical, and social science occupations + reference48121 job details job summary: As the largest staffing and recruitment agency in the world, we can commit to finding you...
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