Quality assurance manager Jobs in Rochester, MN

Sr. Specialist/Principal Specialist Quality Assurance

Rion Inc.

Rochester, MN

Full time

New

The Company

Rion is a clinical-stage biotechnology company based in Rochester, Minnesota. Rion was founded as a Mayo Clinic Employee Entrepreneurial Program startup company. Rion's mission is to develop clinically impactful and accessible therapies using innovative regenerative medicine technologies based on extracellular vesicle science. Our proprietary exosome platform has the ability to address significant unmet patient needs in many fields of medicine; accordingly, we are actively pursuing clinical programs in wound healing, cardiovascular diseases, and women's health. Our ultimate mission is to deliver cutting edge solutions accessible to any patient in need, anywhere in the world.

The Position

As a Specialist in the Quality Assurance department, this position plays a key role in ensuring our products meet all requirements. This position will integrate with internal development, manufacturing, and laboratory functions as well as external contract manufacturers and laboratories. This individual will have the opportunity to grow and expand responsibilities as Rion advances through stages of development.

Job Responsibilities:

• Review of and support of the creation and approval of manufacturing documentation, e.g. master batch records, risk assessments, and equipment qualifications.
• Creating and revising standard operating procedures supporting the quality system
• Reviewing executed batch records and dispositioning materials for clinical and commercial use
• Review/approval of facilities/equipment/process validation protocols and reports
• Quality lead in working with contract manufacturing and testing organizations providing services to Rion
• Supporting development protocols and reports
• Provide Quality Assurance support of GMP laboratory, including:
• Performing data review of executed laboratory analyses
• Issuing controlled analytical forms and laboratory notebooks
• Review of certificates of analysis / test
• Participate, oversee, and approve of quality events such as complaints, deviations, change controls, and laboratory investigations.
• Support ongoing improvements in Rion's quality system and overall compliance to regulations

Qualifications:

A bachelor's degree in chemistry, biology or a related field, and a minimum of seven years of GMP manufacturing and/or GMP laboratory industry experience are required. An equivalent combination of a graduate degree and experience sufficient to successfully perform the job duties as listed above is acceptable.

Additional Information:

Schedule: Monday - Friday

Work Location: Rochester, MN

Work Remotely: No

Relocation Assistance: Yes

Job Type: Full-time, Exempt

Direct Reports: 0+

The Benefits

Rion recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue career path their goals, both at work and in their personal lives. We provide a competitive compensation package with a unique culture focusing on development and wellbeing of our staff. Below are some of the benefits offered by Rion:

• Full Health, Dental and Vision Insurance for employees and their dependents.
• Choice between PPO or High Deductible Health Plan with Health Savings Account (HSA)
• Flexible Spending Accounts (FSA)
• 401K or IRA Retirement Savings Plan
• Life Insurance Programs
• Short and Long-Term Disability Insurance
• Paid Time-off, Paid Holidays, and Parental Leave programs
• Parking Benefits

EEO Statement

Rion is proud to be an equal opportunity employer that complies with all applicable federal, state and local fair employment practices laws. Rion strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law.

Recruitment & Staffing Agencies

Rion does not accept agency resumes unless contacted directly by internal Rion Talent Acquisition. Please do not forward resumes to Rion employees, or any other company locations; Rion is not responsible for any fees related to unsolicited resumes.