Quality Control Engineer II - CRB
Job ID 347095 Date posted 11/21/2024- Rochester, MN
- Full Time
- Regenerative Biotherapeutics
- Remote: No
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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
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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