Quality Assurance Specialist

Specialist, Quality Assurance

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 manufacturing and laboratory functions as well as external contract packagers. This individual will have the opportunity to grow and expand responsibilities as does our company as Rion advances through stages of development.

Job Responsibilities:

Provide Quality Assurance support of GMP product manufacturing and development, including: ·

• Maintaining master batch records and material inspection plans
• Creating and revising standard operating procedures
• Issuing production records
• Reviewing executed batch records and dispositioning materials
• Working with contract manufacturers that package Rion products
• Supporting development protocols and reports

Provide Quality Assurance support of GMP laboratory, including:

• Performing data review of executed laboratory analyses
• Creating and revising standard operating procedures
• Issuing sample data packets and laboratory notebooks
• Issuing certificates of analysis·
• Oversee the document control room and retention of GMP documentation
• Perform investigations on customer complaints and support deviations, change controls, and laboratory investigations

Qualifications:

• A bachelor’s degree in chemistry, biology or a related field, and a minimum of five years of GMP manufacturing and/or GMP laboratory industry experience are required.
• 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.

o Choice between PPO or High-Deductible Health Plan with Health Savings Account (HSA)

o Flexible Spending Accounts (FSA)

· 401K or IRA Retirement Savings Plan

· Life Insurance Programs

o Basic life and supplemental life insurance options for self, spouse, children

· 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.

Job Type: Full-time

Pay: $75,000.00 - $115,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Relocation assistance
• Retirement plan
• Vision insurance

Application Question(s):

• Applicants must be authorized to work in the United States without employer sponsorship now or in the future

Experience:

• GMP: 5 years (Required)

Work Location: In person

Salary : $75,000 - $115,000