Associate II, Quality Assurance, 2nd Shift at Moderna Therapeutics in Norwood, Massachusetts

Job Description:

The Role:
Moderna is seeking a Quality Assurance Associate II 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 2nd shift, 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. They will be able to 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:

• Participate in quality focused teams across Moderna's broad ecosystem of functions.




• Authors and reviews SOPs, policies and batch production/testing records to ensure compliance and adherence to regulations/cGMP operations.




• Oversee and review executed electronic and paper batch record documentation.




• Develop batch records, SOPs and training materials for startup of the Norwood Facility




• 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 2 years of 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; Associates with 4+ years related experience or 5+ years of related GMP experience




• 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




• Experience with tech transfer desired.

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 care.com


• 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:

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. 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 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 auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.

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.

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