Quality Control Engineer II - Center for Regenerative Biotherapeutics

Mayo Clinic • Rochester, MN

2h • $73,736 - $110,552

About The Position

The Quality Control Engineer II for the Center for Regenerative Biotherapeutics (CRB) is responsible for performing quality control assays, including release, in-process and stability tests. This role also involves performing environmental monitoring within clean rooms and leading assay development and validation tasks as directed by a supervisor. The position provides qualification and validation support for manufacturing processes essential to clinical production. All GMP related activities must be performed strictly according to SOPs with accurate and complete documentation, in compliance with cGMP, principles of Data Integrity, and good documentation practices. The role includes performing investigations and process improvements, such as CAPAs and Change Controls, and ensuring compliance with all applicable Federal and State accrediting agency requirements for biopharmaceutical products manufactured in the cGMP facility. The engineer will participate in identifying, optimizing, and validating new analytical procedures as necessary, and assist in reviewing and revising Standard Operating Procedures. General laboratory activities as assigned by the supervisor are also part of the responsibilities. The role requires completing and maintaining updated training for assigned tasks and training others where qualified. Data review and support for internal and external audits are also key functions.

Requirements

• Experience performing quality control assays (release, in-process, stability).
• Experience with environmental monitoring within clean rooms.
• Experience with assay development and validation.
• Experience with qualification and validation of manufacturing processes.
• Experience performing GMP related activities strictly according to SOPs.
• Experience with accurate and complete documentation.
• Knowledge of cGMP principles.
• Knowledge of Data Integrity principles.
• Experience with good documentation practices.
• Experience performing investigations and process improvements (CAPAs, Change Controls).
• Knowledge of Federal and State accrediting agency requirements.
• Experience identifying, optimizing, and validating new analytical procedures.
• Experience reviewing and revising Standard Operating Procedures.
• Experience performing general laboratory activities.
• Ability to complete and maintain updated training.
• Ability to train others where qualified.
• Experience reviewing data.
• Experience supporting internal and external audits.

Responsibilities

• Perform quality control assays, including release, in-process and stability tests.
• Perform environmental monitoring within clean rooms.
• Lead assay development and validation tasks as directed by supervisor.
• Provide qualification and validation support for manufacturing processes.
• Perform all GMP related activities strictly according to SOPs with accurate and complete documentation.
• Perform investigations and process improvements including CAPAs and Change Controls.
• Ensure compliance with all applicable Federal and State accrediting agency requirements.
• Participate in identifying, optimizing, and validating new analytical procedures.
• Assist in reviewing and revising Standard Operating Procedures.
• 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.

Benefits

• Medical: Multiple plan options.
• Dental: Delta Dental or reimbursement account for flexible coverage.
• Vision: Affordable plan with national network.
• Pre-Tax Savings: HSA and FSAs for eligible expenses.
• Retirement: Competitive retirement package to secure your future.
• Continuing education and advancement opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed