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 in San Diego, CA is seeking a Quality Control (QC) Specialist I. This is an onsite position and will report to the Senior QC Scientist. The QC Specialist has a strong understanding of products (QC testing, specifications, QC processes, assay knowledge) within the assigned work cell. This role may act as Lead for their work cell, scheduling activities, communicating with Production Planners,

Primary responsibilities for role:

Executes experiments for troubleshooting non-conformances and/or assay technique issues.

Participates in quality audits (QC assessments, internal, 3rd party).

Initiates and leads document change control activities. Able to create/revise QC documents (procedures and specification documents).

Supports the work-cell lead with test scheduling.

Acts as a lead trainer for QC work-cell.

Initiates clear and concise LI/OOS investigations

Performs and documents investigations using standard root cause determination methods

Initiates clear and concise non-conformances. Performs and documents low severity investigations.

Leads a QC department team or participates on cross-functional teams.

Technical Writing Skills, Continuous improvement methodology

Performs routine testing including release testing, performance testing, analytical testing, bioburden testing, environmental monitoring using GMP/GLP practices.

Performs data analysis and results interpretations comparing to specifications, validity criteria, alert limits.

Participate in QC Method Qualifications

Responsible for revising QC documents (SOPs, QSs)

Participates in Lab Investigations and Out of Specification investigations.

May act as the primary QC trainer in specific test methods

May be responsible for writing non-conformance investigations with the assistance of a QC Specialist or Supervisor

May lead a small team for continuous improvement projects

Responsible for maintaining product and QC material inventories.

Responsible for the maintenance and cleanliness of the laboratory, stocking shelves/drawers with testing materials.

Responsible for the maintenance and cleanliness of equipment, calibrating or submitting items for calibration as needed.

Knowledge, Skills, and Abilities

Working knowledge of Enterprise Resource Planning (ERP), QSR, GMP/GLP requirements.

Working knowledge of industry/regulatory standards.

Intermediate computer skills

Education

B.A. or B.S in life sciences

Experience

4 years of relatable quality control 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.

Occupational Demands

Must be able to lift up to 25 lbs

Pay Scale

The estimated pay scale for the QC Specialist I role based in San Diego, CA , is $73,834.60 to 92,293.25 per year. Additionally, the position is eligible to participate in up to 5 % 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, including those with arrests or conviction records, in a manner consistent with the requirements of applicable state and local laws, including the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Learn more about Grifols

Req ID: 523482

Type: Regular Full-Time

Job Category: Quality