Moderna Therapeutics Inc. Looking for Specialist, Quality Control, Technical Specialist at Norwood, Massachusetts Full Time

The Role

In this role, you will support QC Labs with review of test records and manage QC Quality records (e.g. Change Controls, deviations, CAPA, Lab investigations, etc.) as well as author/update cGMP documents.

Here’s What You’ll Do

• Review executed QC test records for product release, including the investigation and resolution of deviations, OOS and OOT observations.

• Work with QC group to maintain and update all necessary training documentation including; On-The-Job Trainings, Training Materials, Instructor Led Training, and Knowledge Checks.

• Supports authoring and revision of laboratory procedures and reports

• Support authoring quality systems records such as deviations, change controls, CAPAs as required

• Supports team to Investigate and resolve issues related to assay failures, system deficiencies, deviations, and equipment / assay troubleshooting.

• Lead projects as assigned

• Additional duties may be assigned

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

• BA or BS degree in Biology, Microbiology or similar field

• 5+ years of direct experience in pharmaceutical QC Microbiology with experience in different Microbiological Assays such as Endotoxin, Sterility, Bioburden, Growth Promotion, Microbial Identification and environmental monitoring. TOC, pH and conductivity experience desired.

• Previous experience reviewing data for GDP/GMP compliance as well as audit trail review

• Previous experience managing quality records such as change controls, deviations, and lab investigations

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

• In depth understanding of compendial microbiology testing and techniques per USP, EP and JP requirements

• Experience with rapid microbiological methods

• Expertise in aseptic technique training and concepts

• Experience with performing laboratory and deviation investigations

• Experience in Technical writing and SOPs

• Proficiency with Microsoft Office Programs

• Familiarity with electronic databases (e.g. LIMS, SAP, LMS, MODA)

• Demonstrated ability to work effectively under established guidelines and instructions

• Ability to collaborate effectively in a dynamic, cross-functional matrix environment

• Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations

• Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment

• Excellent communication skills (verbal and written)

• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

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

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit (url removed).

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 (url removed). (EEO/AAP Employer)

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