ModernaTX, Inc. seeks a Supervisor, Quality Control for its Norwood, Massachusetts location.
Here's What You'll Do:
Responsible for analytical instrumentation systems for Quality Control (QC) departments (Chemistry, BioAssay, Microbiology, Raw Materials, Stability, Sample Management).
Serve as a liaison between QC and key stakeholders and service providers, including Facility & Engineering, IT, and outside vendors.
Responsible for life cycle management of laboratory instrumentation per FDA, ICH, EMA, and other regulatory requirements.
Ensure current industry and regulatory practices are incorporated in equipment handling processes and systems.
Manage QC lab equipment pre-purchase activities.
Manage equipment onboarding, Installation, Operation, Performance Qualification (IOPQ), validation, release, and decommissioning process to support QC operation.
Oversee all QC laboratory assets operation, health, troubleshooting, readiness and availability for QC use.
Ensure maintenance and calibration activities are executed on time and optimize time needed to minimize impact on operations.
Manage QC service provider qualification program.
Maintain the QC equipment records in Enterprise Asset Management Program.
Create equipment team metrics and monitor/improve KPIs. Review and approve equipment IOPQ and validation documents.
Monitor QC equipment performance and approve QC periodic review documents.
Manage QC Controlled Temperature Unit (CTU) alarm acknowledgement and impact assessments.
Manage equipment deviation and Out of Tolerance (OOT) investigations.
Partner with the Digital team to facilitate lab automation to QC operation efficiency.
Ensure laboratory equipment meet data integrity requirements.
Ensure on time closure of equipment quality system records such as deviations, change controls, Corrective and Preventative Actions (CAPA), and Proactive Initiative (PI).
Provide QC support for the review and approval of equipment documentation including risk assessment, policies, SOPs, and validation protocols/reports, calibration and maintenance, etc.
Participate in cross functional planning to align QC resources and constraints with business objectives.
Support and participate in preparation, management and response to compliance audits.
Provide equipment support for method troubleshooting, remediation, change and optimization efforts in cross functional teams.
Author and revise Equipment SOPs. Train QC analysts on equipment operation as needed.
Responsible for continuous improvement of equipment team procedures, processes, and compliances.
Support cross-functional process improvement projects.
Responsible for equipment team recruiting, training, performance review, mentoring, and career development.
Will supervise one (1) Quality Control Associate II and one (1) Quality Control Specialist.
Here's What You'll Bring to the Table:
Minimum requirements:
Requires a minimum of a Bachelor's degree, or foreign equivalent, in Pharmaceutical Sciences or related field and five (5) years of progressive, post-baccalaureate experience in the position offered, or as Chemist, Analytical Chemist, Chemistry Supervisor, QC Supervisor, or related position in a cGMP environment. Alternatively, employer will accept a Master's degree in fields specified and three (3) years of the specified experience.
Must have at least 3 years of experience with:
Analytical lab testing and equipment troubleshooting leveraging test methods and chromatographic software;
Supporting preparation, management, and response to compliance audits;
Managing continuous improvement projects;
Leading deviation investigations, change controls, and Corrective Actions and Preventive Actions (CAPAs); and
Authoring and reviewing equipment documentation including risk assessment, policies, Standard Operating Procedures (SOPs), and validation protocols/reports, calibration, and maintenance records.
Apply at https://modernatx.wd1.myworkdayjobs.com/en-US/M_tx (Job ID: R17138) or email resume and cover letter to careers@modernatx.com with subject line: R17138.
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) #LI-NT1 -
