Senior Quality Assurance Specialist

Taking care of people is at the heart of everything we do, and we start by taking care of you!!! A career at Grifols means experiencing our culture of caring. It’s an opportunity to do something meaningful, each day. It means sharpening your skills and growing your career. And it means working in an environment that celebrates diversity and is fair and inclusive! 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. Their multifaceted responsibilities encompass complaint handling, customer support, leading improvement initiatives, and meticulous document review. In addition, they serve as the key interface between quality assurance and auditing bodies, facilitating effective communication with both external auditors and internal departments. They may also supervise relevant tasks without formal evaluations. Primary Responsibilities Independently handles complaints, investigations, performs root causes, assigning additional actions as necessary. Review, update, or create SOPs to standardize current and new processes. Apply knowledge of regulatory bodies such as CAP, CLIA, AABB, CFR to identify, manage, and follow‑up on quality events. Lead cross‑functional teams from internal departments or outside vendors to establish appropriate processes for product quality improvements, ensuring implementation, sustainability, and monitoring field quality. Represent QA interests on special projects related to area of expertise. Plan and conduct scheduled internal audits to assess compliance with FDA, ISO, MDR, and internal requirements; schedule audits, investigate findings, report, follow‑up, and confirm action. Proactively investigate, identify, and implement best‑in‑class quality system practices and manage improvement projects such as CAPA, QMP, STAR, Lean, 5S. Drive awareness and compliance with applicable SOPs, work instructions, standards and regulations; interact with regulatory and partner auditors/inspectors. Estimate, plan, schedule, and review own and others’ work products and be accountable for quality work delivered. Knowledge, Skills, and Abilities Advanced knowledge of complaint handling, testing instruments (hardware and software), QC, manufacturing and inventory processes. Working knowledge of QMS, Microsoft Word, Excel (or other data trending/analysis tools), PowerPoint and related functions, including graph formulation. Organizational skills, attention to detail and ability to prioritize in a fast‑paced environment. Demonstrate initiative, independence, balanced assertiveness, flexibility, and team orientation. Ability to train and mentor within and outside the group. Plan and coordinate own work according to higher‑level project schedules; direct contract personnel to ensure timely project delivery. Education Requires BA or BS in biology, chemistry, biochemistry, or any science‑related field. Quality certifications such as MT, MLS, CLS and ASQ or equivalent are preferred. 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 related education and experience may be considered in place of the stated requirements. Benefits Salary in line with the market and an annual bonus. Target‑paid vacation, PTO, holidays. Parental leave. 401(k) retirement plan with employer match: 100% match on first 4% of eligible compensation contributed, and 50% match on next 2%. Vision, travel accident insurance, life, AD&D insurance, short‑ and long‑term disability insurance. Health Savings Account, Flexible Spending Account. Critical illness, accident, hospital indemnity coverage. #J-18808-Ljbffr