Specialist/Senior specialist, Aesthetics Quality Assurance Rion Inc. - 3.3 Rochester, MN Job Details Full-time 2 days ago Benefits Health savings account Paid holidays Disability insurance Health insurance Dental insurance 401(k) Flexible spending account Paid time off Family leave Parental leave Vision insurance Life insurance Qualifications Biology Laboratory procedures Document control experience within pharmaceutical industry Data Retention (Data management) Production deviation management Filing Mid-level Internal investigations Bachelor's degree in biology Manufacturing standard operating procedures Manufacturing facility experience Records retention Laboratory quality control records management Bachelor's degree Quality assurance experience within pharmaceutical industry Laboratory standard operating procedures Quality inspection Chemistry Collaboration with manufacturing teams Production batch record review Standard operating procedures (SOPs) Bachelor's degree in chemistry Standard operating procedures drafting Pharmaceutical manufacturing facility experience Full Job Description Come work with RION in the heart of downtown Rochester, a vibrant rapidly-growing city located in Southeast Minnesota. Located in the home of the number one hospital in the country, time and again, Rochester, MN, ranks among the best places to live in the United States owing to its affordable cost of living, healthy lifestyle, stellar school systems, and exceptional quality of life. Rochester is also well known as a global destination for health and wellness. For the past decade, state officials in collaboration with the Mayo Clinic and City of Rochester, have implemented Destination Medical Center, a 20-year, $5.6 billion economic development initiative focused on developing Rochester as a global epicenter for life sciences and healthcare innovation. Utilizing public and private investments, Rochester is creating an inviting ecosystem for biotechnology start-up ventures looking to capitalize on a skilled and educated workforce.
MISSION AND VISION
Re-Imagining Medicine We seek to change the approach to regenerative medicine by utilizing exosome technology to improve the lives of more patients, in more places, across more diseases, from every walk of life. Specialist/Senior specialist, Aesthetics Quality Assurance About Rion Rion is a clinical-stage biotechnology company based in Rochester, Minnesota, founded through the Mayo Clinic Employee Entrepreneurial Program. Our mission is to develop clinically impactful and accessible therapies using innovative regenerative medicine technologies based on extracellular vesicle science. Rion's proprietary exosome platform aims to address significant unmet patient needs across multiple therapeutic areas, including wound healing, cardiovascular disease, and musculoskeletal diseases. Position Summary 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. Choice between PPO or High Deductible Health Plan with Health Savings Account (HSA) Flexible Spending Accounts (FSA) 401K Retirement Savings Plan Life Insurance Programs Basic life and supplemental life insurance options for self, spouse, children Short and Long-Term Disability Insurance Discretionary 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. All resumes can be sent to Our Perks Health Insurance Dental Insurance Vision Insurance Flexible Spending Accounts (FSA) 401K or IRA Retirement Savings Supplemental Life Insurance Short and Long-Term Disability Insurance Paid Family Leave Paid Time Off Paid Holidays Parking Benefits Health Insurance Dental Insurance Vision Insurance Flexible Spending Accounts (FSA) 401K or IRA Retirement Savings Supplemental Life Insurance Short and Long-Term Disability Insurance Paid Family Leave Paid Time Off Paid Holidays 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.
