Clinical Sr. QA Specialist - CLIA/CAP

Grifols, S.A; San Marcos (TX); Vor Ort; USD 80.000 - 100.000; Vollzeit

Benefits dieser Stelle

Annual bonus

Paid Vacation

401(K) Retirement Plan

Health Savings Account

Life and Disability Insurance

Zusammenfassung

A leading global healthcare company is seeking a QA Sr. Specialist to provide oversight in laboratory operations. The role involves complaint handling, leading improvement initiatives, and ensuring compliance with quality standards. Candidates should possess a BA or BS in a related field and have 5-8 years of experience in quality assurance. This position offers competitive compensation along with a comprehensive benefits package including healthcare, retirement plans, and paid time off.

Qualifikationen

• 5-8 years of quality experience in complaint handling and investigation.
• Must demonstrate initiative, independence, and team orientation.
• Ability to train and mentor within the group.

Aufgaben

• Independently handle complaints and investigations.
• Review/update/create SOPs for standardizing processes.
• Lead cross-functional teams for product quality improvements.

Kenntnisse

Complaint handling

Testing instruments

Organizational skills

Microsoft Word

Microsoft Excel

Project scheduling

Ausbildung

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

Quality certifications (MT, MLS, CLS, ASQ)

Tools

Quality Management System (QMS)

Data analysis tools

Jobbeschreibung

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 of Interacts with regulatory and partner auditors/inspectors.

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.
• Will also estimate, plan, schedule and review own and others’ work products and be accountable for the quality work delivered.

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
• 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)
• 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

EEO Minorities/ Disability/Veterans

Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws.