Quality Control Engineer II – CRB

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. You’ll thrive in an environment that supports innovation, is committed to ending racism and supporting diversity, equity and inclusion, and provides the resources you need to succeed.

Responsibilities

We are seeking a Quality Control Engineer II with a strong background in microbiology, including hands-on experience with various bacteria, fungi, and yeast, their growth conditions. The ideal candidate will have experience working in a cGMP-regulated environment and will be responsible for performing quality control assays (release, in-process, stability), and supporting assay development and validation.

Key responsibilities include conducting GMP activities according to SOPs, performing investigations (CAPAs, Change Controls), ensuring compliance with regulatory requirements, and assisting in the validation of new testing procedures. Familiarity with data integrity, documentation practices, and environmental monitoring is essential. This role also involves training, supporting audits, and contributing to process improvements.

The Quality Control Engineer II 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. This position is not eligible for F-1 OPT STEM extension.

Exemption Status

Exempt

Compensation Detail

$70K – $105K / year;

Benefits Eligible

Yes

Schedule

Full Time

Hours/Pay Period

80

Schedule Details

Monday – Friday 8:00 a.m. – 5:00 p.m.; Rotating weekends and on-call rotations

Weekend Schedule

Rotating weekends 1 every 5th weekend as well as on-call rotations

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.

Affirmative Action and Equal Opportunity Employer

As an Affirmative Action and Equal Opportunity Employer Mayo Clinic is committed to creating an inclusive environment that values the diversity of its employees and does not discriminate against any employee or candidate. Women, minorities, veterans, people from the LGBTQ communities and people with disabilities are strongly encouraged to apply to join our teams. Reasonable accommodations to access job openings or to apply for a job are available.

Recruiter

Kaela Peterson

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