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Sr. Specialist, Quality Control

Employer
Moderna, Inc.
Location
Marlborough, MA
Start date
Feb 22, 2024

View more

Discipline
Clinical, Clinical Medicine, Quality
Required Education
Bachelors Degree
Position Type
Full time

Job Details

The Role

Moderna is looking for a Senior Quality Control Specialist for their Marlborough, MA location. This role involves maintaining and supporting the life cycle of QC equipment, as well as providing training support. The specialist will collaborate with various teams to achieve company goals and might also assist in investigating Quality Events.

Heres What Youll Do

  • Track and report on the status of instrument life cycles, including acquisition, relocation, decommissioning, and qualification activities, using project management tools.

  • Serve as the point person in QC for all equipment inquiries and relay to appropriate vendors.

  • Assist with quality systems records such as deviations, change controls, CAPAs as required.

  • Support efforts for method troubleshooting remediation, change, and optimization efforts in cross-functional teams.

  • Write, revise, and manage standard operating procedures (SOPs) for equipment, instruments, and training.

  • Perform data entry, analysis, trending, and review.

  • Assist in the streamlined onboarding of new Quality Control staff.

  • Collaborate with management/peers and coordinate all required training for current and future staff.

  • Provide feedback to management on developmental status of new staff during training sessions.

  • Coordinate with the Quality Assurance training group to create, maintain, and update all required training documentation, including on-the-job training, training materials, and instructor-led training sessions.

  • Instruct staff on general laboratory support tasks such as preparing reagents, managing samples, maintaining equipment, and general lab upkeep.

  • Maintain cGMP documentation for work performed.

  • Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.

  • 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 the assigned required learning plan according to the defined timing and the prescribed requalification cadence.

Heres What Youll Bring to the Table:

  • Bachelor's degree in a relevant scientific discipline.

  • 6-8 years of experience in a cGMP Quality Control environment

  • Ability to understand GxP regulations.

  • Desire to impact a high-growth, transformational company with a bold, relentless, curious, and collaborative culture.

Desired Attributes:

  • Strong leadership and management skills.

  • Excellent communication and interpersonal skills.

  • Problem-solving and troubleshooting abilities.

  • Ability to work collaboratively across departments.

  • Commitment to safety and quality.

  • Vision for continuous improvement and innovation.

  • Strategic thinking aligned with organizational goals.

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, 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.

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 make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

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Company

Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. Moderna’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.

mRNA is now a turning point in the history of science, medicine, technology, even humankind itself. With this breakthrough discovery, many of the world’s biggest and most challenging medical problems are no longer a question of “how?” but merely a question of “when?”

Come with us as we pursue the uncharted reaches of possibility and make your mark on the future of medicine.

 

Stock Symbol:

MRNA  

Stock Exchange:

USNASDAQ GS

 

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Company info
Website
Phone
617-714-6500
Location
200 Technology Square
Cambridge, MA
United States

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