QC Specialist

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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.

Summary: 

Grifols Diagnostics Solutions is seeking a Quality Control (QC) Specialist to join our team. This position is located in Rancho Bernardo – San Diego, CA. In this role, you will perform routine testing and data analysis, participate in QC method qualification and quality audits, and execution of experiments.

 

We are looking for individuals with at least 4 years of relatable QC experience. The QC Specialist will have a strong understanding of products (QC testing, specifications, QC processes, assay knowledge) within the assigned work cell. This role may act as a lead for their work cell, participate in scheduling activities, and communicating with Production Planners.

                                                           

 Primary responsibilities for role:

• 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 or action limits.  
• Participate in QC Method Qualifications
• 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.
• Executes experiments for troubleshooting non-conformances and/or assay technique issue.                                               
• 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.                                                  
• Responsible for completing training in a timely manner and maintaining the records.
• 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 team.

                                       

Additional Responsibilities:                                                          

Technical Writing Skills, Continuous improvement methodology

 

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 a Biological Science or Chemistry

 

Experience:

4 years of professional QC experience in a GMP laboratory role

                                                                                                                

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 this Quality Control (QC) Scientist I role based in San Diego, CA, is $67,739 to $84,647. 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 an