What are the responsibilities and job description for the Compliance and Regulatory Affairs Intern position at Asuragen, Inc.?
By joining Bio-Techne, you’ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.
Pay Range:
$16.80 - $23.10Compliance Summer Intern
Introduction: Research and Development are not the only professional opportunities for life science graduates. Come spend your summer with us in Austin, Texas, and learn all about the Quality Assurance (QA) and Regulatory Affairs (RA) functions at Asuragen, a Bio-Techne brand! QA and RA partner closely with Research, Development, Bioinformatics, Software and Operations through the Design Control process to bring discoveries made in the research laboratory to the clinical market to improve health outcomes for patients.
Position Summary: The In Vitro Diagnostics (IVD) Compliance Summer Intern will have the opportunity to apply their scientific knowledge work closely with the Quality Assurance and Regulatory Affairs Teams at Bio-Techne’s Asuragen site based in Austin, Texas. internal colleagues as a key member of the Quality Assurance team working to maintain and grow Asuragen’s Quality Management System in alignment with international quality and regulatory standards.
This is a summer internship position with an expected duration of approximately eight weeks.
Key Responsibilities:
Learn about global regulatory standards, systems, procedures, and practices including ISO 13485, FDA QSR, MDSAP, IVDR, and other compliance requirements by working closely with the QA and RA teams
Gain valuable real-life experience through contributing to the preparation and execution (including follow-up) of Asuragen’s annual Quality System Surveillance audit.
Work with your designated QA and RA mentors on a bespoke IVD Compliance Project
Support the overall Quality goals and QA Department goals.
Generate metrics in support of Quality Management Reviews.
Other duties as assigned.
Education and Experience:
Current undergraduate student pursuing a degree in the Life Science field having completed at least 60 credit hours at an accredited four-year college or university.
Knowledge, Skills, and Abilities:
Strong desire to explore the importance of quality assurance and regulatory compliance within the In Vitro Diagnostic industry
Excellent written and oral communication skills.
Excellent analytical and problem-solving skills with the ability to work independently with minimal supervision.
Excellent organizational and communication skills, with the ability to assist in documentation and report preparation.
Detail-oriented and able to work collaboratively in a team environment to achieve compliance goals.
Skilled in the use of software programs such as Microsoft Office and database management programs.
Detail oriented and skilled at examining documents for accuracy and completeness. Ability to prepare records in accordance with detailed instructions.
Ability to set priorities and meet deadlines on a personal level. Ability to work under tight deadlines.
Prior experience or coursework in quality assurance, regulatory affairs, or a related field is a plus.
Knowledge of medical device regulations and standards will be beneficial.
Join us for an exciting opportunity to learn contribute to ensuring the quality and compliance of in vitro diagnostics through this internship program!
Why Join Bio-Techne:
We have an incredibly talented group of down-to-earth professionals with the experience, drive and creativity that makes Bio-Techne a world-class global diagnostics company. Our workplace is full of enthusiastic, hardworking, and intelligent people with bold ideas and the determination to see them through.
Our best-in-class reagents, instrument, custom manufacturing, and diagnostic tests are used throughout a patient’s lifespan by laboratories worldwide. Bio-Techne has locations in Minneapolis, MN, Austin, TX, Boston, MA, Denver, CO and San Jose, CA and all sites offer top-notch technology, educational, and business benefits. Science is our passion; it drives us to collaborate, develop and manufacture award-winning tools that help researchers achieve reproducible and consistent results.
Bio-Techne provides a competitive salary, medical, dental, disability and life insurance, a 401(k) plan with company matching, an employee bonus plan, and a tuition reimbursement plan. We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic.
Where permitted by applicable law, candidate must have received or be willing to receive an FDA authorized COVID-19 vaccine by date of hire to be considered for this position.
Bio-Techne is an E-Verify Employer in the United States.
Why Join Bio-Techne:
We offer competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.
We invest in our employees’ financial futures through 401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.
We empower our employees develop their careers through mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more.
We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.
We offer an accrued leave policy with paid holidays, paid time off, and paid parental leave.
We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.
Bio-Techne is an E-Verify Employer in the United States.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
To protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property.
Salary : $17 - $23
