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Specialist, Quality Assurance, 3rd Shift

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Company :
Moderna

Location :
Norwood, Massachusetts

Expiry Date :
Mon, 21 Dec 2020 23:59:59 GMT

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Description :
The Role Moderna is seeking a Quality Assurance Specialist for support and oversight of internal Clinical manufacturing at Moderna Inc. This position will be based in our cGMP Manufacturing site in Norwood, MA. This position will be 3rd shift from 11:00 pm to 7:00 am, Wednesday through Saturday. The individual in this role will be part of a cohesive team responsible for supporting cGMP mRNA drug products produced internally at Moderna. He/she will provide quality oversight and expertise to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. The successful candidate will have experience in quality oversight or manufacturing experience in early stage clinical products. Strong decision-making skills and independent thinking will be paramount for candidate success. He/She will interact fluidly with peers and supervisors in Manufacturing, and cross-functionally with Quality Control, Manufacturing, Logistical and Process Development Technology Transfer counterparts. Here’s What You’ll Do – Perform routine walkthroughs of the manufacturing suites partnering with manufacturing on suite maintenance, Quality best practice implementation and troubleshooting when problems arise. – Authors and reviews SOPs, policies to ensure compliance and adherence to regulations/cGMP operations. – Oversee and review executed electronic and paper batch record documentation. – Reviews minor manufacturing deviations. – Closely partner with peers for disposition of Plasmid, Drug Substance and Drug Product – Demonstrate general knowledge of standard manufacturing compliance, quality disposition, quality system review. – Enforce adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation. Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data. – Monitor process operations to ensure compliance with specifications. – Practice safe work habits and adhere to Moderna’s safety procedures and guidelines. – Utilize knowledge to improve operational efficiency. – Participate in quality oversite of manufacturing through real-time observations of activities. Here’s What You’ll Bring To The Table – At least 5 years’ experience in a GMP manufacturing environment with a Bachelor’s degree in Biology, Chemistry, Chemical engineering, Biomechanical engineering, Bioengineering, Biomedical engineering, Biochemistry or related field – Proven track record of success in a fast-paced production environment at a biotech/pharmaceutical company preferably in GMP or GLP – Ability to collaborate fluidly with peers, supervisors and cross functional support groups required – Exceptional written, oral communication, and organizational skills required Here’s What We’ll Bring To The Table – On-site subsidized cafeteria or catered lunches – Company-provided iPhone – Free parking, monthly subway pass or a subsidized commuter rail pass – Free annual corporate membership to Bluebikes – Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP – Flexible Spending Accounts for medical expenses and dependent care expenses – 16 weeks of 100% paid parental leave for all new parents – 16 weeks 100% paid family caregiver leave – 20 weeks 100% paid medical leave – Eligible for Moderna Month (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter) – Adoption assistance and discounts to local childcare centers, as well as access to – 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately – A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability – Voluntary legal assistance plan – 15 days’ vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays) About Moderna Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The Company’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna 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, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators. Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been ranked in the top ten of Science’s list of top biopharma industry employers for the past five years. To learn more, visit . Our Mission Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients. Moderna is a smoke-free, alcohol-free and drug-free work environment. Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.