QA Specialist

JOB REQUIREMENTS: Do you like working behind-the-scenes, but want a jobthat impacts people in your community? Then consider becoming a QualityAssurance Specialist at The Community Blood Center. By joining our team,you'll play a critical role in this life-saving mission. JOB SUMMARY:The Quality Assurance Specialist is a full-time position responsible forensuring compliance with regulatory, accreditation, certification, CBC,and customer requirements. This role supports the implementation ofeffective manufacturing processes and system controls to promotecontinuous product safety and quality. The specialist ensures currentGood Manufacturing Practices (cGMPs) are adhered to and integratedacross all organizational systems. ESSENTIAL DUTIES AND RESPONSIBILITIES(other duties may be assigned): 1. Maintains and recommends improvementsto The Community Blood Center's Quality Plan. 2. Reviews and implementsSOP's and training documents related to Quality Assurance processes andsystems in order to ensure regulatory compliance. 3. Reviews andcritiques SOP's and training documents submitted from departmentmanagement for adherence to current FDA, AABB, and other regulatoryguidelines. 4. Provides training and education regarding quality, cGMP,and safety for the organization. 5. Manages the change control processfor policies, processes and procedures, which may include theimplementation of new/revised documents, and the archiving of olddocuments. 6. Assists users of quality management software in analysisand reporting of data. 7. Participates in quality improvement andcorrective action teams within and across operational areas. 8. Reviewsdata from quality management software and other sources to identifytrends. Communicates trends to management. 9. Reviews equipment andprocess validation documentation. 10. Evaluates deviations andnon-conformances reported via the deviation management system and othersources. Determines if immediate correction is appropriate or should beevaluated for corrective action. Escalates to management errorsrequiring further evaluation and/or submission of reports to FDA. 11.Participates in the tracking, monitoring, and reporting of qualityindicators. Performs trend analysis to monitor process and facilityperformance. 12. Develops audit plans, conducts quality audits, preparesaudit reports and communicates findings, including compliance risk. 13.Assists with external inspections as needed. 14. Assures quality serviceto all customers. 15. Complies with all policies and procedures outlinedin the CBC Employee Handbook, Center SOP's, and/or directives.Maintains current level of job-related skills by attending in-services,training sessions, and reading publications. 16. Performs all otherduties, at the discretion of management, as assigned. OTHEREXPERIENCE AND QUALIFICATIONS: JOB QUALIFICATION REQUIREMENTS:Bachelor's degree preferred. Experience in medical technology or aclinical allied health field is preferred. 1-3 years of experience in ablood center, biologics, pharmaceutical or medical industrymanufacturing environment with base familiarity of quality assurancepractices, training, and federal regulatory practices is preferred.Excellent organizational, oral, and written communication skills. Stronganalytical and problem-solving skills. Strong, flexible interpersonalskills. Skilled in observation of operational tasks. Skilled indocumentation review with special emphasis on details. Computer skillswith emphasis on word processing and database software Employee mayoccasionally be required to lift objects or materials weighing up to 25pounds. APPLICATION INSTRUCTIONS: Apply Online:

Created: 2026-01-26