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Compliance Technician

3 months ago

Raleigh, United States Proesis Biologics Inc Full time
Job DescriptionJob DescriptionDescription:

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 Raleigh is looking to add a Compliance Technician to their team The ideal candidate for this position will have exceptional attention to detail, can analyze complex events and will understand and comply with all state and federal regulations, Standard Operating Procedures (SOPs), and internal procedures. The Compliance Technician will work in coordination with the Quality Assurance Manager and Center Director to manage ongoing center performance. This position will also conduct reviews of all center recorded events and will play a huge role in preparing the center for routine audits.


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 Raleigh, 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:

  • 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.
  • Analyze complex events to identify opportunities for improvement using data driven decision making.
  • 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.
  • This role will learn how to perform venipuncture on a donor as a portion of center training.

Qualifications and Education:

  • High School Diploma or Equivalent Required
  • Minimum 2 years’ experience in a federally regulated environment required.
  • Available to work flexible and/or extended shifts as needed.
  • Flexibility to work outside of normal business hours.
  • 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.