Quality Assurance Specialist

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 our new Katy, TX Center 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 Katy, 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.

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:

• Will work in coordination with the Quality Assurance Manager and Center Director to manage ongoing employee training.
• Works in coordination with donor center staff to ensure continuous training initiatives are completed per company expectations the Proesis Biologics Training Program and Standard Operating Procedures (SOP).
• Engage with Center Director, Quality Assurance Manager and Corporate Training Designee to facilitate the employee training process and manage basic Learning Management System functions.
• Maintains all documentation relevant to training and employee development within the Donor Center.
• Assists Center Management in identification, evaluation, and development of Area Experts.
• Will be certified to function in all working areas of the Donor Center, including Donor Screening, Phlebotomy, and Plasma Processing.
• Will be required to become a Subject Matter Expert (SME) in all working areas of the Donor Center to oversee training and guidance to center employees.
• Assists with training needs associated with internal and external audit findings and/or regulatory and operational requests.

Qualifications and Education:

• High School Diploma or Equivalent Required
• Must be comfortable learning venipuncture.
• Minimum 2 years’ experience in a federally regulated environment required.
• Flexibility to work outside of normal business hours.
• Available to travel as necessary for special projects.
• Must demonstrate a strong work ethic, excellent communication, and organizational skills.
• Demonstrated ability to work with computer-based applications and software.
• Demonstrated history of working in compliance-driven environment.

Physical Demands:

• Ability to sit or stand for extended periods for up to four (4) hours at a time.
• Ability to tug, lift, and pull up to fifty (50) pounds.
• Be able to bend, stoop or kneel and climb stairs or ladder.
• Occupational exposure to bloodborne pathogens.
• While performing the duties of this job, the employee is regularly required to stand; use hands to, handle or feel objects, tools, or controls.
• The employee must be able to enter a walk-in freezer at the Center with a temperature of -40 Celsius for short periods of time.
• Specific vision and hearing abilities are required to be successful within the role.

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.