Grifols · 20 hours ago
Sr. QA Specialist
San Marcos, TX
Full-time
Onsite
Senior Level
5+ years expGrifols is a global healthcare company that has been working to improve the health and well-being of people around the world since 1909. 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, including complaint handling and leading improvement initiatives.
BiotechnologyHealth CareManufacturing
Responsibilities
Independently handles complaints, investigations, performs root causes, assigning additional actions as necessary
Review/update/create 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/outside vendors to establish appropriate processes for product quality improvements. Ensures implementation/sustainability and monitors the field quality of the improvements
Represents 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. To include audit scheduling, investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions
Pro-actively investigate, identify, and implement best in class Quality Systems practices and implement/manage improvement projects within the organization; (CAPA, QMP, StAR, Lean, 5S)
Drive awareness and compliance with applicable standard operating procedures/ work instructions / standards and regulations to meet, comply and champion all quality and regulatory commitments of Interacts with regulatory and partner auditors/inspectors
Qualification
Required
Requires BA or BS in biology, chemistry, biochemistry or any science related field
5-8 years related quality experience in complaint handling and investigation or a Master's degree with 3-6 years of experience
Advanced knowledge of complaint handling, testing instrument (hardware and software), QC, Manufacturing & Inventory processes
Working knowledge of QMS, Microsoft Word, Excel (or other data trending/analysis tools), Power Point and related functions including the formulation of graphs
Organizational skills, attention to detail and ability to prioritize in a fast-paced environment is essential
Must demonstrate 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 projects come to fruition in a timely manner
Will also estimate, plan, schedule and review own and others' work products and be accountable for the quality work delivered
Independently handles complaints, investigations, performs root causes, assigning additional actions as necessary
Review/update/create 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/outside vendors to establish appropriate processes for product quality improvements. Ensures implementation/sustainability and monitors the field quality of the improvements
Represents 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. To include audit scheduling, investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions
Pro-actively investigate, identify, and implement best in class Quality Systems practices and implement/manage improvement projects within the organization; (CAPA, QMP, StAR, Lean, 5S)
Drive awareness and compliance with applicable standard operating procedures/ work instructions / standards and regulations to meet, comply and champion all quality and regulatory commitments of Interacts with regulatory and partner auditors/inspectors
Preferred
Quality certifications such as MT, MLS, CLS and ASQ or equivalent are a plus
Benefits
Paid Vacation, PTO, holidays
Parental leave
Professional development opportunities (training, career development)
Gym pass, Employees perks program
401 (K) Retirement Plan (Grifols will match 100% on the first 4% of eligible compensation you contribute, and 50% on the next 2% of eligible compensation you contribute)
Health insurance: Medical, Dental, Vision
Travel accident insurance; Life and AD and D Insurance, Short- & Long-Term Disability Insurance
Health Savings Account, Flexible Spending Account
Critical Illness, Accident, Hospital Indemnity coverages
Adoption benefits
Company
Grifols
Grifols is a global healthcare company.
10001+ employees
H1B Sponsorship
Grifols has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2023 (2)
2022 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$2.51BKey Investors
Michael J. Fox Foundation
2025-01-14Grant· $21M
2024-06-04Post Ipo Debt· $1.41B
2024-04-23Post Ipo Debt· $1.07B
Leadership Team
Camille Alpi
Chief Human Resources Officer
Víctor Deu
Director of Planning & Control Department
Recent News
2025-12-24
Pharma Letter
2025-11-28
2025-11-19
Company data provided by crunchbase