Quality Assurance Engineer Job Summary
We are seeking a Quality Assurance Engineer for a position based at their Norwood, MA manufacturing site. This position is part of the 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 Drug Product filling at the Norwood Site. The individual will work closely with Analytical Development, Process Development, Manufacturing, Materials Management, Quality Control, Digital, and the Manufacturing Science and Technology 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 our 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. Job Responsibilities
Education & Qualifications
- 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. 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 filling process of Drug Product. This includes providing plan creation oversight, verifying that changes adhere to SOPs and regulatory compliance.
- 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
- Requires a Bachelor's Degree (Engineering or Scientific discipline)
- 2-5 years of Quality Assurance experience in pharmaceutical industry providing oversight to Drug Product filling activities
- 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 judgement and decision-making abilities
- Demonstrated problem detection and problem resolution skills
- Must possess demonstrated organizational skills
- Must possess excellent verbal and written
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.