(Contract) Sr. Associate, Quality Assurance

Employer
Moderna
Location
Norwood, MA
Salary
Competitive
Posted
March 07 2019
Ref
R1471
Discipline
Life Sciences, Biology
Organization Type
Biotech
(Contract) Sr. Associate, Quality Assurance

The Role:
Reporting to the Sr. Manager, the QA Associate II/Sr. QA Associate will be responsible for supporting the provision of quality oversight for the cGMP manufacturing of personalized cancer vaccines at the Norwood, MA site. The main responsibilities for this position will be adjusted based on the level that the personnel will be hired at. The anticipated time frame for this role is 10 months.

Here's What You'll Do:
  • Review executed batch records and perform technical review of documentation post-execution of cGMP activities. Ensures all specifications are met and that applicable requirements are completed and acceptable.
  • Participate in providing on the floor quality oversight of manufacturing by conducting room changeovers and real-time observations of manufacturing activities.
  • Collaborate with Manufacturing to resolve equipment and process issues.
  • 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 work on minor and/or some major deviations. Oversees execution of remediation/CAPA activities required to continue production or move a process to the next mile stone. Works closely with team members 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. This includes verifying that changes adhere to SOPs and regulatory compliance.
  • Conduct internal checks as assigned for compliance with SOPs, GMPs and regulations.
  • Work closely with others to recognize opportunities for improvement and drive change using Quality systems.


Here's What You'll Bring to the Table:
  • BS in Microbiology, Biology, or Chemistry with 2-4 years of QA Operations experience in pharmaceutical industry providing oversight to manufacturing operations OR MS degree with 0-2 years' experience.
  • 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.

Our Mission:
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

#LI-DNI

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.

Similar jobs

Similar jobs