(Contract) Specialist, Quality Assurance
Reporting to the Sr. Manager, the QA Specialist will be responsible for providing quality oversight for the cGMP manufacturing of personalized cancer vaccines at the Norwood, MA site. The main responsibility for this position is to provide quality oversight of the manufacturing process for drug substance and drug product formulation.
Here's What You'll Do:
- Author and review SOPs, test methods, protocols and reports. Create and establish process and procedures to ensure compliance and adherence to regulations and cGMP operations.
- Identify, classify and report deviations, as appropriate and typically works on more complex minor and/or major deviations. Oversees execution of remediation/CAPA activities required to continue production or move a process to the next mile stone. Works closely with others to determine root cause and potential preventative/corrective actions. Ensure timely closure of investigation.
- Responsible for providing quality oversight to the change management system for change controls. This includes providing plan creation oversight, verifying that changes adhere to SOPs and regulatory compliance.
- Review pre-executed batch records and independent technical review of documentation post-execution of cGMP activities. Ensures all specifications are met and that applicable requirements are completed and acceptable.
- Participate in quality oversight of manufacturing, real-time observations of activities
- Collaborate with Manufacturing to resolve equipment and process issues
- Conduct internal audits, track progress, and trend results
- Work closely with others to recognize opportunities for improvement and drive change using Quality systems
- Participate in internal audits for compliance with SOPs, GMPs, and regulations
Here's What You'll Bring to the Table:
- A Bachelor's degree in microbiology, biology, or chemistry.
- 2-5 years of quality assurance experience in pharmaceutical industry providing oversight to manufacturing operations.
- Demonstrated knowledge of cGMPs in a manufacturing environment.
- Strong independent judgement and decision-making abilities.
- Demonstrated problem detection and problem resolution skills.
- Must possess demonstrated organizational skills.
- Must possess excellent verbal and written skills.
- Ability to effectively collaborate effectively in a fast-paced, dynamic, cross-functional matrix environment.
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.