What are the responsibilities and job description for the Quality Assurance Specialist position at Proesis Bio?
Job Type
Full-time
Description
Proesis Biologics is a contemporary and forward-thinking human source plasma collection platform dedicated to improving the plasma donation journey for all stakeholders. We partner with communities and donors to supply the industry with the high-quality plasma necessary for treating people with rare and chronic conditions worldwide. We strive to create a collaborative and engaging culture focused on bold authenticity, intense curiosity and innovation, fierce donor advocacy, and growth.
Our Proesis Bio team in Dallas is looking to add a Quality Assurance Specialist to their team! The ideal candidate for this position will have exceptional attention to detail, strong training experience, and should be able to analyze complex events and to understand and comply with all state and federal regulations, Standard Operating Procedures (SOPs), and internal procedures. As a Quality Assurance Specialist, this team member will work alongside the Quality Assurance Manager to manage ongoing and continuous staff training. This position will also conduct reviews of all Center recorded events and will play a huge role in preparing the center for routine audits. This role will learn how to perform venipuncture on a donor as a portion of center training.
Enough with the formalities. Are you ready to work for an organization that truly values you as a person, not just a worker? We don't simply say our employees are our most valuable resource, we live it with emphasis on providing outstanding benefits related to your time (our PTO and paid Holidays are legit!); health and dental insurance; wages (some sources show we pay in the top 10-15% of the market); and much, much more. By joining our team at Proesis Bio Dallas, you will not only be embarking on an exciting professional journey, but you'll also have the chance to make a real, tangible difference in the lives of people across our global communities, each and every day. If we have your attention, please continue reading to learn more about the role.
Requirements
Role and Requirements :
Quality :
- Consistently demonstrate the company's Core Values while working with Proesis Biologics employees, staff, and vendors.
- Maintains and controls quality systems and programs to ensure compliance with internal and customer defined quality standard requirements.
- Learns and maintains familiarity and compliance with all state and federal regulations, Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP), and internal procedures.
- Ensure compliance with all federal, state, local, and company-specific rules, regulations, and practices related to the quality and safety of products, donors, and employees.
- Conducts reviews, both manual and electronic, of all recorded center events including those associated with the donor, product, or process.
- Responsible for preparing the center for internal and external audits; responsible for supporting center audits including preparation and review of requested documentation, policies, etc.
- Ensures product is collected, stored, and shipped per Company Standard Operating Procedures.
- Works in collaboration with clients and vendors to ensure center needs are met and controlled.
Training :
Qualifications and Education :
Physical Demands :
At Proesis, we don't just accept difference - we celebrate it, we support it, and we thrive on it for the benefit of our employees, our products, and our community.