Quality Analyst - FDA Regulated Manufacturing

Mayo Clinic; Rochester (MN); On-site; USD 78,270 - 117,312; Full time

Benefits offered by this job

Medical plan options

Dental coverage or reimbursement

Vision coverage

HSA and FSAs

Retirement package

Job summary

Mayo Clinic in Rochester, MN seeks a Quality Analyst, FDA Regulated Manufacturing, to ensure regulatory compliance in product manufacturing. You will lead QMS implementation and partner across departments to integrate quality into operations.

The role requires a bachelor’s in a science field and at least five years in quality, with knowledge of FDA GMPs, ISO, and related regulations. ASQ certification encouraged; visa sponsorship not available.

Qualifications

• Bachelor’s degree in science and 5+ years in a quality-related field.
• Knowledge of laws, regulations and guidance related to FDA regulated industries (biologics, pharmaceuticals).
• Experience with FDA GMPs, ISO certification and quality systems (SOPs, audits, documentation).
• Excellent written and verbal communication and strong organizational skills.

Responsibilities

• Implement quality and regulatory compliance for product manufacturing activities.
• Lead the Quality Management System (QMS) and ensure quality integrated into operations.
• Collaborate across departments to identify and mitigate regulatory and compliance risk.

Skills

Quality assurance

Regulatory compliance

QA leadership

Analytical thinking

Written and verbal communication

Education

Bachelor's degree in science (e.g., biology, chemistry)

Tools

Quality Management System (QMS)

Job description

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

The Quality Analyst, FDA Regulated Manufacturing is responsible for implementation of quality and regulatory compliance for product manufacturing activities. The Quality Analyst directs the work to identify and reduce regulatory, accreditation, and compliance risk by continuous monitoring and evaluating current facility policies and practices to ensure compliance is built into the operational systems. Is accountable for the effective implementation of the Quality Management System (QMS) and serves as the local subject matter expert on the policies, processes and procedures of the QMS by developing a broad knowledge of the practice, business and technology as it relates to product manufacturing. This position may be required to take direction from management staff across multiple departments and develop expertise in multiple types of products manufactured at Mayo Clinic (i.e., medical devices, tissues, cellular therapies, etc.).

Qualifications

A bachelor’s degree is required, preferably in a science related field (e.g. biology, chemistry, etc.) and a minimum of 5 years of experience in a quality-related field. Knowledge and experience in the application of laws, regulations, and guidance documents related to FDA regulated industries (biologics, pharmaceuticals, etc.) and previous experience with FDA GMPs, EU regulations, and/or ISO certification for product manufacturing is preferred, along with knowledge of quality systems (e.g. SOPs, audits, documentation practices, etc.). Exceptional human relations and communication (written, verbal, and listening) skills are required. Organizational project management skills are essential, along with analytical and critical thinking skills. Must be flexible and capable of adapting to and facilitating change. Should be very detail-oriented and have the ability to work independently and productively with minimal direction, and routinely exercise initiative and sound judgment. Must have the ability to lead, motivate and influence others. Compliance issues may create difficult situations for the individuals involved; therefore, objectivity and professionalism is essential. Must have demonstrated capacity to comprehend complex protocols, programs, and situations. The ability to exercise good judgment in ambiguous situations while under pressure and tight deadlines, and strong coping skills are required. Must be flexible in adapting to a variety of responsibilities, work assignments, and priorities. Must also be flexible with work schedule as needed to meet customer needs. Experience working in a research environment is preferred. Must be self-motivated and able to independently schedule workday activities with minimal direction. ASQ certification in quality and/or GMP principles (e.g., quality process analyst, quality improvement associate, etc.) are strongly encouraged. Note: Visa sponsorship is not available for this role. Must be U.S. citizen, permanent resident, refugee or asylee.

Exemption Status

Exempt

Compensation Detail

$78,270.40 - $117,312.00/ 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

Monday - Friday, normal business hours

Weekend Schedule

Flexibility based on business needs

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.