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.

Grifols Diagnostic Solutions Inc is seeking a Quality Specialist III in San Diego, CA. The Quality Specialist III will be responsible for ensuring compliance with applicable domestic and international standards and regulations through review of Device History Records (DHRs) for products manufactured at the GDS San Diego site. Perform Enterprise Resource Planning (ERP) transactions such as product usage decision and releases product to inventory. Reviews and approves product expiration date extension reports. Tracks KPIs and provides feedback to cross-functional teams. Owns nonconformance and CAPA records. Supports Quality Inspection of materials as needed.

To succeed in this role, individuals must have at least a BA or BS in a biological or chemical science, Quality certification (from American Society for Quality or equivalent), is a plus. Along with 5-8 years related quality experience and working understanding of QSR & ISO requirements.

Primary Responsibilities:

• Reviews and approves Design History Records (DHRs), Device Master Records, Document Changes, Validations and Change Controls.

• Ownership, management, and processing of nonconformances, Out-of-Tolerance Reports, and CAPA records. Supports Quality Inspection as needed.

• Conducts compliance audits of difficult & complex documentation and data and approve use of Design History Records, Device Master Records, Nonconformances, Document Changes, Validations and Change Controls.

• Demonstrates working knowledge of Quality Control, Manufacturing and Inventory processes.

• Leads internal, external & 3rd party audits.

• Serves as QA interface with limited responsibilities to other departments.

• Reviews Customer Notifications and prepare, approve & submit data packages for external customers.

• Supports internal and/or external audits in compliance with ISO 13485 and 21CFR820 requirements.

• Participates in 3rd Party Audits from regulatory bodies including the FDA, notified bodies and business partners.

• Assists in developing quality systems & make recommendations for improvements to existing Quality systems.

• Approves compliance assessments & interfaces with other departments and business partners for complaints, investigations, etc.

• Chairing meetings as appropriate such as Complaint Review Board (CRB), Material Review Board (MRB) and Product Quality Committee (PQC), Change Control Board (CCB), and other meetings.

• Prepares appropriate Agendas and meeting minutes.

• Monitors the progress of items on the meeting Agendas and reports progress, as appropriate.

• Chairs meetings & represents QA as an extended core team member on Core team and cross functional special project teams.

• May conduct new employee quality system or procedural training and develop department training programs.

• Conducts complex technical troubleshooting activities & investigation analysis.

• Performs technical support of QA Systems.

• Develops, analyze, trend, maintains & reports department metrics, as needed.

• Reviews and assesses the appropriateness of document changes in accordance with internal procedure.

• Reviews and assesses change control, validation, and qualification documents, as applicable.

• Creates & approves Master Lot protocols, regulatory protocols & provide technical review for validations.

• Assists in developing quality systems & make recommendations to existing Quality systems.

• Administers QA Programs such as Audit, ECO/DCR CAPA & QSR.

• Develops & maintains department training programs.

• Review and assess the appropriateness of document changes in accordance with internal procedures of a difficult and complex nature.

• Assists in decision making at meetings for recalls, MDRs, field corrections &/or market recalls.

• Acts as a mentor to QA personnel.

Education:

• Requires BA or BS in a biological or chemical science.

• Quality certification (from American Society for Quality or equivalent), is a plus.

Experience:

• 5-8 years related quality experience.

• Working understanding of QSR & ISO requirements

• Advanced knowledge of QC, Manufacturing & Inventory processes

• Working knowledge of Microsoft Word, Excel, 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.

Occupational Demands

May occasionally lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight, and/or lift, carry, push, pull or otherwise manipulate objects of a negligible weight frequently or continuously. Sedentary work involves sitting the majority of time. Jobs are sedentary if walking and standing are required only occasionally.

Pay Scale

The estimated pay scale for Quality Specialist III role based in San Diego, CA is $96,655.20 to 120,819 per year. Additionally, the position is eligible to participate in up to 8 % of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws.

Learn more about Grifols (https://www.grifols.com/en/what-we-do)

Req ID: 525284

Type: Regular Full-Time

Job Category: Quality