Clinical Sr. QA Specialist - CLIA/CAP

Summary The QA Sr. Specialist plays a pivotal role in laboratory operations, providing essential oversight and guidance, with a primary focus on clinical and manufacturing testing. Responsibilities include complaint handling, customer support, leading improvement initiatives, meticulous document review, and serving as the key interface between quality assurance and auditing bodies. Primary Responsibilities Independently handles complaints, investigations, performs root cause analysis, and assigns additional actions as necessary. Reviews, updates, and creates SOPs to standardize current and new processes. Applies knowledge of regulatory bodies such as CAP, CLIA, AABB, CFR to identify, manage, and follow up on quality events. Leads cross‑functional teams from internal departments or outside vendors to establish appropriate processes for product quality improvements, ensuring implementation, sustainability, and monitoring of field quality. Represents QA interests on special projects related to area of expertise. Plans and conducts scheduled internal audits to assess compliance with FDA, ISO, MDR, and internal requirements, including audit scheduling, investigation, evaluation, reporting, follow‑up, and confirmation of actions. Proactively investigates, identifies, and implements best‑in‑class quality systems practices; manages improvement projects such as CAPA, QMP, StAR, Lean, and 5S. Drives awareness and compliance with applicable SOPs, work instructions, standards, and regulations; interacts with regulatory and partner auditors/inspectors. Estimates, plans, schedules, and reviews own and others’ work products, and is accountable for the quality of deliverables. Knowledge, Skills, and Abilities Advanced knowledge of complaint handling, testing instrument (hardware and software), QC, manufacturing, and inventory processes. Working knowledge of QMS, Microsoft Word, Excel, and related data analysis tools, including graph formulation. Strong organizational skills, attention to detail, and ability to prioritize in a fast‑paced environment. Demonstrates initiative, independence, balanced assertiveness, flexibility, and team orientation. Ability to train and mentor within and outside the group. Can plan and coordinate own work according to higher‑level project schedules, including direction of contract personnel to ensure timely project completion. Education and Certifications Requires a BA or BS in biology, chemistry, biochemistry, or any related science field. Quality certifications such as MT, MLS, CLS, ASQ, or equivalent are a plus. Experience 5‑8 years of related quality experience in complaint handling and investigation, or a Master’s degree with 3‑6 years of experience. Equivalency Depending on the area of assignment, directly related experience or a combination of directly related education and experience or competencies may be considered in place of the stated requirements. For example: if a job level requires a bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an associate’s degree with 6 years of experience, or a master’s degree with 2 years of experience. Benefits Salary in line with the market and an annual bonus target. Paid vacation, PTO, and holidays. Parental leave program. Professional development opportunities (training, career development). Gym pass and employee perks program. 401(k) retirement plan with matching contributions. Health insurance: medical, dental, and vision. Travel accident, life, AD and D insurance, short‑ and long‑term disability insurance. Health savings account and flexible spending account. Critical illness, accident, and hospital indemnity coverages. Adoption benefits. Location North America: USA – Texas, San Marcos North America: USA – Texas, Austin North America: USA – Texas, San Antonio #J-18808-Ljbffr Grifols