The Role
Moderna is seeking a Quality Control Specialist based at their Norwood, MA site. The individual in this role will focus on Quality Events including phase I/II OOS and OOT investigations, Deviations, Change Controls, and CAPA’s for the Quality Control group. This individual may support special projects (e.g. metrics) as needed.
Here’s What You’ll Do
Support and own various quality systems records such as deviations, change controls, CAPAs, and OOS/OOT investigations for cGMP Quality Control
Perform data entry and support trending analysis
Supports authoring and revision of equipment, method, and other laboratory procedures and reports
Complete and maintain cGMP documentation (electronic and hard copy) for work performed
Work with Quality Assurance to close records in a timely manner
Assist in process improvement projects within multi-disciplined team
Here’s What You’ll Need (Minimum Qualifications)
Bachelor’s degree in a relevant scientific discipline with at least 4 years in a cGMP setting with focus in Quality Control or Quality Assurance
Here’s What You’ll Bring to the Table (Preferred Qualifications)
Experience with QC Chemistry analytical techniques (e.g. HPLC, UV/Vis Spec, and GC)
Experience with directing investigations in a QC environment, performing root cause analysis, and addressing the root cause.
Experience with technical writing within a GMP regulated QC environment.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
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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