Clinical Sr. QA Specialist - CLIA/CAP

Grifols; San Marcos (TX); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health insurance

401(k) plan with company match

Paid vacation

Job summary

Grifols is seeking a QA Sr. Specialist to provide essential oversight of clinical and manufacturing testing, handle complaints, and lead quality improvement initiatives. You will interface with auditors and internal departments to ensure compliance with FDA, ISO, and CFR requirements.

The role requires strong knowledge of QMS and experience in coordinating cross-functional teams, SOP updates, and CAPA projects within a regulatory framework.

Qualifications

• BA/BS in biology, chemistry, biochemistry or related field.
• Quality certifications such as MT, MLS, CLS or ASQ or equivalent are a plus.
• 5–8 years quality experience in complaint handling and investigation or a Master’s with 3–6 years.
• Knowledge of CAP, CLIA, CFR, FDA, ISO, MDR requirements.

Responsibilities

• Independently handles complaints and investigations, assigns actions.
• Review/update/create SOPs to standardize processes.
• Lead cross-functional teams for product quality improvements.
• Plan and conduct internal audits per FDA, ISO, MDR.
• Coordinate with regulators and auditors; ensure timely follow-up actions.

Skills

Complaint handling

Regulatory awareness

Documentation & data analysis

Training & mentoring

Project coordination

Independent work

Education

BA/BS in biology, chemistry, biochemistry or related field

Tools

Microsoft Word

Excel

PowerPoint

Job description

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well‑being of people around the world. We are leaders in plasma‑derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

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 For Role

• 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 ofInteracts with regulatory and partner auditors/inspectors.
• Will also estimate, plan, schedule and review own and others’ work products and be accountable for the quality work delivered.

Knowledge, Skills, And Abilities

• 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.

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 a plus.

Experience

5-8 years 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 and/or competencies may be considered in place of the stated requirements. 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.

More About Us, Benefits We Provide You

• Salary in line with the market as well as an annual bonus target
• Paid Vacation, PTO, holidays
• Parental leave program
• 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

Location: NORTH AMERICA : USA : TX-San Marcos || NORTH AMERICA : USA : TX-Austin || NORTH AMERICA : USA : TX-San Antonio:[[cust_building]]

Learn more about Grifols