Quality Assurance Specialist (QC Microbiology), GMP
Moderna is seeking a Quality Assurance Specialist for a position based at their Norwood, MA manufacturing site. This position is part of Moderna's Quality Assurance team responsible for ensuring quality oversight of our mRNA platform in cGMP Manufacturing. The main responsibility for this position is to provide quality oversight of microbiological testing conducted for manufactured product; including: mRNA drug substance, bulk lipid nanoparticle (LNP), and drug product; providing quality oversight for Environmental Monitoring of the Norwood Site; and water testing. The individual will work closely with Manufacturing, Materials Management, Quality Control, and Digital teams.
This position will also support the successful launch of Phase I and II products to the clinic in a timely manner. Ensure quality oversight is phase appropriate and scale-able. Assist in the startup of clinical drug product cGMP manufacturing operations at Moderna's new facility in Norwood, MA. Success in this position requires expertise in all aspects of aseptic drug product manufacturing, the ability to work hands on, and the ability to collaborate in a cross-functional, fast paced environment.
Here's What You'll Do:
- Drive investigations to help resolve any contamination incidents to minimize consumer risk
- Authors and reviews SOPs and policies. Create and establish process and procedures to ensure compliance and adherence to regulations and cGMP operations.
- Identifies, classifies and reports deviations, as appropriate and typically works on more complex minor and/or major deviations. Oversees execution of remediation/CAPA activities required to continue production, move a process to the next mile stone, or prevent re-occurrences of microbial contamination. Works closely with others to determine root cause and potential preventative/corrective actions. Ensure timely closure of investigations.
- Responsible for providing quality oversight to the change management system for change controls related to microbiological testing and/or Environmental Monitoring. This includes providing plan creation oversight, verifying that changes adhere to SOPs and regulatory compliance.
- Review data related to cleaning of manufacturing equipment to support batch processing. Ensures all specifications are met and that applicable requirements are completed and acceptable.
- Participate in quality oversight of manufacturing and testing, real-time observations of activities.
- Work closely with others to recognize opportunities for improvement and drive change through the use of Quality systems.
- Participate in internal audits for compliance with SOPs, GMPs, and regulations.
- Other activities as deemed necessary e.g. raw material release
Here's What You'll Bring to the Table:
- Requires a Bachelor's degree in Microbiology
- 2-5 years of quality assurance experience in pharmaceutical industry providing microbiological oversight
- Ability to translate complex issues into a meaningful set of recommendations that can be understood by non-microbiologists
- Demonstrated knowledge of cGMPs in a manufacturing environment
- Strong independent judgment and decision-making abilities
- Demonstrated problem detection and problem resolution skills
- Must possess demonstrated organizational skills
- Must possess excellent verbal and written
Here's What We'll Bring to the Table:
- Daily on-site catered lunches.
- Company-provided iPhone.
- Free parking, monthly subway pass or a subsidized commuter rail pass.
- 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.
- 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.
- Adoption assistance, competitive parental leave, discount to local childcare centers, as well as access to Care.com
Why join Moderna Therapeutics
We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching. It could transform not only how certain diseases are treated but also how medicines are discovered, developed and manufactured - at a breadth, scale and speed not common in the biopharma industry.
Since our founding in 2011, we have built the industry's leading mRNA technology platform, the infrastructure to accelerate drug discovery and speed early development, a rapidly expanding pipeline, and an unparalleled team. Our development pipeline includes development candidates for mRNA-based vaccines and therapies spanning several therapeutic areas, and we have multiple clinical trials already underway with other development candidates progressing toward the clinic. In addition, we have a number of discovery programs that are advancing toward the development stage.
We invite you to explore our site to learn more about our company and how we are advancing the promise of mRNA science to improve health and impact lives around the world.
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
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.