Specialist, Quality Control

Moderna Theraputics Norwood , MA

Posted 2 months ago

The Role:

Reporting to the Sr. Manager, Quality Control, this individual will be responsible for facilitating rollout and assisting management of Moderna's Quality Control Digital roadmap. This role will be crucial in the enhancement of QC digital operations at the Norwood, MA site.

This role will also play a key role in lifecycle management of QC digital operations.

Here's What You'll Do:

  • Responsible for facilitating strategic expansion and execution of quality control digital systems and applications

  • Partner with Digital on cross functional digital lab systems projects

  • Serve as business representative for critical QC digital systems changes

  • Participate in digital system validation activities including business process analysis, test script development and execution

  • Work with the quality control management team to continuously improve the quality, compliance and efficiency of QC operations

  • Collaborate with QC subject matter resources to coordinate implementation of changes

  • Work collaboratively with the QC leadership team to define and defend data integrity policies and practices for Quality Control

Here's What You'll Bring to the Table:

  • BS/BA and minimum 5-7 years or MS with 3+ experience in cGMP environment; 2 - 4 years in a lab analyst role

  • In-depth knowledge of relevant FDA, EU, ICH guidelines and regulations.

  • Experience with various digital quality systems such as LIMS, Lab Execution System, SDMS

  • Strong knowledge of digital quality systems (LIMS, QMS, CDS) preferred.

  • Experience with system validation

  • Excellent quality control judgment and ability to assess, communicate and resolve complex issues efficiently and effectively.

  • Outstanding communication skills (verbal and written).

  • Ability to manage multiple projects in a fast-paced environment.

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

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)

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19. Newly hired employees must be vaccinated prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

About Moderna

In 10 years since its inception, Moderna has transformed from a science 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 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. Moderna has been named a top biopharmaceutical employer by Science for the past seven 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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VIEW JOBS 5/11/2021 12:00:00 AM 2021-08-09T00:00 The Role: Reporting to the Sr. Manager, Quality Control, this individual will be responsible for facilitating rollout and assisting management of Moderna's Quality Control Digital roadmap. This role will be crucial in the enhancement of QC digital operations at the Norwood, MA site. This role will also play a key role in lifecycle management of QC digital operations. Here's What You'll Do: * Responsible for facilitating strategic expansion and execution of quality control digital systems and applications * Partner with Digital on cross functional digital lab systems projects * Serve as business representative for critical QC digital systems changes * Participate in digital system validation activities including business process analysis, test script development and execution * Work with the quality control management team to continuously improve the quality, compliance and efficiency of QC operations * Collaborate with QC subject matter resources to coordinate implementation of changes * Work collaboratively with the QC leadership team to define and defend data integrity policies and practices for Quality Control Here's What You'll Bring to the Table: * BS/BA and minimum 5-7 years or MS with 3+ experience in cGMP environment; 2 - 4 years in a lab analyst role * In-depth knowledge of relevant FDA, EU, ICH guidelines and regulations. * Experience with various digital quality systems such as LIMS, Lab Execution System, SDMS * Strong knowledge of digital quality systems (LIMS, QMS, CDS) preferred. * Experience with system validation * Excellent quality control judgment and ability to assess, communicate and resolve complex issues efficiently and effectively. * Outstanding communication skills (verbal and written). * Ability to manage multiple projects in a fast-paced environment. * Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment. 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. 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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. #LI-LG1 * Moderna Theraputics Norwood MA

Specialist, Quality Control

Moderna Theraputics