Quality Control Specialist 2

GRIFOLS, S.A.•San Diego, CA

1d•$91,225 - $115,000•Onsite

About The Position

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: The QC Specialist 2 acts as a Lead in their workcell and has a strong understanding of products (QC testing, specifications, QC processes, assay knowledge) within the assigned workcell. They have a solid understanding of SQC Trend analysis, Enterprise Resource Planning, and GMP/GLP requirements. The QC Specialist 2 has intermediate technical writing skills, with basic knowledge of experimental design. This role may act as Lead for their workcell, scheduling activities, communicating with Production Planners. Primary responsibilities for role: Performs routine testing as needed. May lead one or more analysts. Designs and executes experiments to troubleshoot non-conformances. Generates, performs and documents laboratory investigations and non-conformances. Uses standard root cause determination methods. Review/analyze data with respect to specifications, validity criteria, alert limits. Oversees lab maintenance duties. Ensures labs are within a state of compliance. Performs periodic lab audits. Initiates and leads document change control activities. Able to create/revise QC documents (procedures and specification documents) Coordinates testing within a work-cell. Communicates closely with planners/QA on product release priorities and issues. Create and approve CofAs. Works closely with QC Scientist on method transfer (NPD). Acts as the lead trainer for QC work-cell. Performs and documents investigations using standard root cause determination methods Assists in software & hardware upgrades including executing test protocols. Initiates clear and concise non-conformances. Performs and documents low severity investigations. Monitors trend dashboards for work-cell product lines. This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed. Additional Responsibilities: Technical Writing Skills, Continuous improvement methodology, Additional responsibilities as assigned

Requirements

Working knowledge of Enterprise Resource Planning (ERP), QSR, GMP/GLP requirements.
Working knowledge of industry/regulatory standards.
Intermediate computer skills
B.A. or B.S
6 years

Responsibilities

Performs routine testing as needed.
May lead one or more analysts.
Designs and executes experiments to troubleshoot non-conformances.
Generates, performs and documents laboratory investigations and non-conformances. Uses standard root cause determination methods.
Review/analyze data with respect to specifications, validity criteria, alert limits.
Oversees lab maintenance duties. Ensures labs are within a state of compliance. Performs periodic lab audits.
Initiates and leads document change control activities. Able to create/revise QC documents (procedures and specification documents)
Coordinates testing within a work-cell. Communicates closely with planners/QA on product release priorities and issues.
Create and approve CofAs.
Works closely with QC Scientist on method transfer (NPD).
Acts as the lead trainer for QC work-cell.
Performs and documents investigations using standard root cause determination methods
Assists in software & hardware upgrades including executing test protocols.
Initiates clear and concise non-conformances. Performs and documents low severity investigations.
Monitors trend dashboards for work-cell product lines.