Regulatory Compliance Specialist

2 weeks ago

Raleigh, North Carolina, United States Proesis Biologics Inc Full time
Position Overview

Proesis Biologics is a modern and innovative human source plasma collection organization committed to enhancing the plasma donation experience for all involved parties. We collaborate with communities and donors to provide the industry with high-quality plasma essential for treating individuals with rare and chronic illnesses globally. Our aim is to foster a cooperative and engaging environment centered on authenticity, curiosity, innovation, and strong advocacy for donors.

Role Summary

Our Proesis Bio team is seeking a Compliance Technician to join our ranks. The ideal candidate will possess remarkable attention to detail, the ability to analyze intricate situations, and a comprehensive understanding of all applicable state and federal regulations, Standard Operating Procedures (SOPs), and internal protocols. This role will involve close collaboration with the Quality Assurance Manager and Center Director to oversee ongoing center performance. Additionally, the Compliance Technician will conduct thorough reviews of all recorded events at the center and play a significant role in preparing for routine audits.

Key Responsibilities
  • Exhibit the company's Core Values while interacting with Proesis Biologics employees, staff, and vendors.
  • Manage and oversee quality systems and programs to ensure adherence to both internal and customer-defined quality standards.
  • Acquire and maintain knowledge of all relevant state and federal regulations, Standard Operating Procedures, Occupational Safety and Health Administration (OSHA) guidelines, Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP), and internal procedures.
  • Ensure compliance with all federal, state, local, and company-specific regulations related to the quality and safety of products, donors, and employees.
  • Conduct both manual and electronic reviews of all recorded center events, including those related to donors, products, or processes.
  • Analyze complex situations to identify improvement opportunities through data-driven decision-making.
  • Prepare the center for internal and external audits, supporting audit processes through the preparation and review of necessary documentation and policies.
  • Ensure that products are collected, stored, and shipped in accordance with Company Standard Operating Procedures.
  • Collaborate with clients and vendors to meet and control center needs.
  • Learn to perform venipuncture on donors as part of center training.
Qualifications
  • High School Diploma or Equivalent Required.
  • A minimum of 2 years of experience in a federally regulated environment is required.
  • Availability for flexible and/or extended shifts as necessary.
  • Willingness to work outside of standard business hours.
  • Strong work ethic, excellent communication, and organizational skills are essential.
  • Proficiency in computer-based applications and software is required.
  • A demonstrated history of working in a compliance-driven environment is preferred.
Physical Requirements
  • Ability to sit or stand for extended periods, up to four (4) hours at a time.
  • Capability to lift and pull up to fifty (50) pounds.
  • Ability to bend, stoop, kneel, and climb stairs or ladders.
  • Exposure to bloodborne pathogens is a possibility.
  • Regularly required to stand and use hands to handle or feel objects, tools, or controls.
  • Must be able to enter a walk-in freezer at the Center with a temperature of -40 Celsius for short durations.
  • Specific vision and hearing abilities are necessary for success in this role.

At Proesis, we embrace diversity — we celebrate it, support it, and thrive on it for the benefit of our employees, our products, and our community.

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