Quality Systems Specialist
CurrentPerform duties in compliance with all applicable regulatory and accrediting agencies. Ensure OSHA regulations and cGMPs are adhered to.Perform occurrence investigations including Occurrence Reports (ORs), Post Donation Information (PDI), Biological Product Deviation Reports (BPDRs), and Quarantine and Lookback (Q&LB) for positive test results.Assist with the review, compilation, and submission of FDA reports, correspondence, product licensing, etc.Develop operational audit plans, perform audits, write audit reports, and issue audit findings to departmentmanagement. Audits include blood center processes, procedures, work areas, electronic queries, anddocuments.Provide support during external agency inspections (FDA, AABB, etc.).Manage record retention process and record storage areas.Facilitate changes to Standard Operating Procedures (SOPs). This may include writing and updating policies,processes, and procedures.Use software to prepare and edit SOPs, attachments, and forms, ensuring:o Use of proper punctuation, grammar, spelling, and styleo Consistency of abbreviations, format, and terminologyo Clarity of content and incorporation of all required materialAssist document owners and management who write and revise SOPs.