Grifols Shared Services North America, Inc QC Specialist 2 in San Diego, California
Grifols is a global healthcare company whose mission is to improve the health and well being of people. Our three divisions –Bioscience, Diagnostic and Hospital–develop, produce and market our innovative products and services to medical professionals in more than 100 countries.
We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. As a company devoted to improving the health and well-being of people, we are looking for talented professionals worldwide. Make a difference and join us in this challenging and rewarding enterprise.
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.
Participates in quality audits (QC assessments, internal, 3 rd party).
Initiates and leads document change control activities. Able to create/revise QC documents (SOPs, QSs, TPs)
Coordinates testing within a work-cell. Communicates closely with planners/QA on product release priorities and issues.
Ensures labs are within a state of compliance. Performs periodic lab audits.
Works closely with QC Scientist on method transfer (NPD).
May act as the lead trainer for QC work-cell.
Create and approve CofAs.
Monitors trend dashboards for work-cell product lines.
May lead a QC department team or a cross-functional team.
Assists in software & hardware upgrades including executing test protocols.
Technical Writing Skills
Analyze and Solve Problems
Business/Technical Skills, Knowledge, Abilities:
Strong understanding of products (testing, specifications, processes, assay knowledge) within the assigned workcell.
Solid understanding of SQC trend analysis.
Advanced knowledge of Enterprise Resource Planning (ERP), QSR, GMP/GLP requirements
Advanced computer skills.
Intermediate technical writing skills.
Basic knowledge of experimental design
Advanced knowledge of industry/regulatory standards.
Education and Expereince:
Requires BA or BS degree and minimum 2 to 8 years related experience
Learn more about Grifols at http://www.grifols.com/es/web/international/home