Quality Control Technical Writer/Investigator, Commercial Quality Control

The Role:

Moderna is seeking a Quality Control Technical Writer/ Investigator based at their Norwood, MA site. The individual in this role will focus primarily on authoring Quality Events including Out of Specification investigations, Out of Trend investigations, Deviations, Change Controls, and Corrective Actions for the Quality Control group. This individual may support special projects as needed.

This position will be expected to work in a highly collaborative, cross functional manner with Quality Assurance, Manufacturing, Analytical Development, Digital/ IT and Manufacturing and provide support to the entire CQC department.

Heres What Youll Do:

• Support and own various quality system records such as deviations, change controls, CAPAs, and OOS/OOT investigations for cGMP Quality Control

• Author Chemistry, Bioassay, Microbiology lab investigations/deviations as well as investigations for QC lab support functions

• Provide metrics/ KPIs for trending analysis

• Author, review, and maintain annual reviews on technical documents as needed

• Support the 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

Heres What Youll Bring to the Table:

• Bachelors degree in a relevant scientific discipline with at least 10 years in a cGMP setting with focus in Quality Control or Quality Assurance or MS with at least 5 years experience

• Experience in authoring Chemistry, Microbiology and Bioassay investigations is preferred

• Knowledge of General laboratory operations, Instrument and Software, Quality Events

• Demonstrated Technical Writing experience is required

• 5+years in a manufacturing site investigator role is preferred

• Ability to think critically and demonstrate troubleshooting and problem-solving skills.

• Strong written and oral communication skills as well as very strong organizational skills

• Knowledge of industry standards and guidelines

• Demonstrated ability to work effectively under established guidelines and instructions

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

• Ability to interact effectively with all levels of personnel within the organization

• Weekend and after hours might be required

• Ability to navigate through ambiguity and rapid growth and adapt to change.

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 winter shut down
  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!

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

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 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 persons 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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