Grifols Shared Services North America, Inc QC Specialist 2 in San Diego, California
Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
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.
Technical Writing Skills, Continuous improvement methodology, Additional responsibilities as assigned
Knowledge, Skills, and Abilities:
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
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.
must be able to lift up to 25 lbs
EEO Minorities/ Disability/Veterans
Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
Req ID: 347729