Quality Control Engineer II - Center for Regenerative Biotherapeutics
About The Position
At Mayo Clinic, our biomanufacturing approach is aligned with industry standards, positioning CRB at the forefront of biotherapeutic commercialization. The Quality Control Engineer II for CRB is responsible for performing quality control assays, including release, in-process and stability tests, performing environmental monitoring within the clean rooms and leading assay development and validation tasks as directed by supervisor, providing qualification and validation support for manufacturing processes that are essential to the clinical production. Perform all GMP related activities strictly according to SOPs with accurate and complete documentation associated with the testing, in compliance with cGMP, principles of Data Integrity and good documentation practices. Perform investigations and process improvements including CAPAs and Change Controls. Ensures compliance with all applicable Federal and State accrediting agency requirements in the testing of biopharmaceutical products manufactured in the current Good Manufacturing Practices (cGMP) facility. Participate in identifying optimizing and validating new analytical procedures for testing as necessary. Assists in reviewing and revising Standard Operating Procedures as necessary. Perform general laboratory activities as assigned by supervisor. Complete and maintain updated all training required to perform assigned tasks and trains others where qualified. Reviews data and supports internal and external audits.
Requirements
- Bachelor’s degree in a biomedical related field and a minimum of 2 years relevant experience within a laboratory or Master’s degree in a biomedical related field
- Technical understanding and experience performing analytical, molecular or microbiological assays
- Ability to analyze data and compose reports
- Effective human relations and communication (written, verbal, and listening) skills
- Flexibility and capability of adapting to and facilitating change
- Demonstrated capacity to comprehend complex protocols, programs, and situations
- Ability to exercise good judgment while working under deadlines
- Flexibility with work schedule as needed
- Must be U.S. citizen, permanent resident, refugee or asylee
Responsibilities
- Performing quality control assays, including release, in-process and stability tests
- Performing environmental monitoring within the clean rooms
- Leading assay development and validation tasks
- Providing qualification and validation support for manufacturing processes
- Performing all GMP related activities strictly according to SOPs with accurate and complete documentation
- Performing investigations and process improvements including CAPAs and Change Controls
- Ensuring compliance with all applicable Federal and State accrediting agency requirements
- Participating in identifying, optimizing, and validating new analytical procedures
- Assisting in reviewing and revising Standard Operating Procedures
- Performing general laboratory activities
- Completing and maintaining updated training
- Training others where qualified
- Reviewing data
- Supporting internal and external audits
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
