Quality Control Engineer II - Center for Regenerative Biotherapeutics

Why Mayo Clinic

Mayo Clinic is top-ranked in more specialties than any other care provider according to U.S. News & World Report. As we work together to put the needs of the patient first, we are also dedicated to our employees, investing in competitive compensation and  comprehensive benefit plans – to take care of you and your family, now and in the future. And with continuing education and advancement opportunities at every turn, you can build a long, successful career with Mayo Clinic.

Benefits Highlights

• 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.

Responsibilities

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.

Qualifications

A 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. A 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 are required. Must be flexible and capable of adapting to and facilitating change. Must have demonstrated capacity to comprehend complex protocols, programs, and situations. The ability to exercise good judgment while working under deadlines is required. Must be flexible with work schedule as needed to meet internal and external customer needs. 

Visa sponsorship is not available for this position. Must be U.S. citizen, permanent resident, refugee or asylee. 

Exemption Status

Exempt

Compensation Detail

$73,736.00 - $110,552.00/ year; Education, experience and tenure may be considered along with internal equity when job offers are extended.

Benefits Eligible

Yes

Schedule

Full Time

Hours/Pay Period

80

Schedule Details

M-F 8-5 with rotating on-call responsibility

Weekend Schedule

As needed to support workload

International Assignment

No

Site Description

Just as our reputation has spread beyond our Minnesota roots, so have our locations. Today, our employees are located at our three major campuses in Phoenix/Scottsdale, Arizona, Jacksonville, Florida, Rochester, Minnesota, and at Mayo Clinic Health System campuses throughout Midwestern communities, and at our international locations. Each Mayo Clinic location is a special place where our employees thrive in both their work and personal lives.  Learn more about what each unique Mayo Clinic campus has to offer, and where your best fit is.

Equal Opportunity

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, protected veteran status or disability status. Learn more about the "EOE is the Law" .  Mayo Clinic participates in  E-Verify and may provide the Social Security Administration and, if necessary, the Department of Homeland Security with information from each new employee's Form I-9 to confirm work authorization.

Recruiter

Stephanie Baird