Hiring: Quality Specialist
Company: CSL Plasma
Location: Winston-Salem, North Carolina / On-Site
Employment Type: Full-time
Seniority Level: Associate level
Estimated Salary: $45,000 - $60,000 per year
Industry: Biotechnology / Pharmaceuticals
Company Overview
CSL Plasma operates one of the world's largest and most sophisticated plasma donation networks, managing nearly 330 donation centers across the United States and Europe.
As a major subsidiary of CSL, a global biopharma leader headquartered in Melbourne, Australia, CSL Plasma collects essential biological materials to manufacture lifesaving, plasma-derived therapies for patients in more than 100 countries.
Employing over 29,000 people globally, CSL fosters a modern enterprise culture centered on inclusion, workplace innovation, comprehensive employee benefits, and strict compliance with global healthcare standards.
Key Responsibilities
Provide direct support to the Assistant Manager of Quality in monitoring plasma center workflows to ensure absolute compliance with CSL Operating Procedures and regulatory guidelines.
Perform final QA review and release procedures for all biological shipments and associated tracking documentation to guarantee adherence to customer specifications.
Investigate, document, and track regulatory or procedural deficiencies, establishing and verifying the effectiveness of required corrective actions.
Manage and maintain center-level personnel training documents, logs, and schedules inside the Learning Management System (LMS) to meet CLIA, COLA, and SOP criteria.
Lead and support internal facility audits, monitor adherence to cGMP, OSHA, and FDA guidelines, and assist in hosting external regulatory or customer inspections.
Initiate, investigate, and close quality variation reports within the Trackwise system in a timely and efficient manner.
Experience & Qualifications
Minimum of 1 year of leadership experience or at least 1 year of professional experience operating within a highly regulated environment.
High school diploma or equivalent required; an Associate or Bachelor’s degree in Business Administration, Biological Sciences, or a related field is preferred.
Strong critical reasoning, decision-making, and analytical problem-solving skills to manage short deadlines and changing priorities.
Solid customer service and communication skills to effectively handle public interactions and coordinate across center departments.
Deep understanding of structural Quality Systems, standard operating procedures, and regulated corporate training structures.
Technical Skills Required
Practical experience working with automated Quality Management Systems (QMS) and specialized compliance tools like Trackwise.
Proficiency in navigating and maintaining digital Learning Management Systems (LMS) for regulatory data integrity.
Knowledge of standard clinical compliance frameworks including cGMP, FDA regulations, CLIA, COLA, and OSHA health policies.
Competence in standard enterprise computing tools, spreadsheet tracking, and technical report generation.
Apply Now
To apply for this quality assurance position at our Winston-Salem facility, please submit your updated application and professional resume through our core candidate enrollment portal.
CSL Plasma offers competitive compensation packages, robust medical benefits, and structured career growth paths across the biopharmaceutical sector.