QC Scientist

GRIFOLS, S.A.•San Diego, CA

3d•$115,000 - $140,000•Onsite

About The Position

Grifols Diagnostic Solutions Inc. is seeking a QC Scientist to provide technical and scientific expertise and analytical leadership within the Quality Control department. The role serves as a high-level subject matter expert in one or more areas of the QC laboratories, including method validation, antigen release and stability, QC raw materials, QC microbial testing (including seedstock), and QC equipment and eSystems programs. The Scientist provides expertise in analytical development, qualification, validation, method transfer, comparability, and troubleshooting of test methods used for lot release, stability, in-process testing, and cleaning methods. The position interacts with Manufacturing Sciences and Technology, Manufacturing, and QC staff for training and technology transfer. The role may focus on programs such as reference and critical reagent qualification, antigen and seedstock stability, seedstock manufacturing, equipment and eSystems, LIMS, analytical method validation, DR and CAPA, EH&S, OE/5S/6S, and QC-specific projects. Work is performed in an office environment, with occasional entry into a BioRisk Area and potential exposure to biological fluids and infectious organisms. Personal protective equipment is required in relevant areas. The role may require driving to site locations and occasional travel within the United States. The position is based in San Diego, California. The estimated annual pay range is $115,000 to $140,000, and the position is eligible to participate in up to 8% of the company bonus pool. Benefits include medical, dental, vision, and life insurance, PTO, paid holidays, up to a 5% 401(k) match, and tuition reimbursement. Final compensation depends on factors including education, experience, skillset, knowledge, work location, internal equity, and market data.

Requirements

Bachelor’s degree in Biochemistry, Molecular Biology, or Immunology with 10 years of experience, or an MS/PhD degree in science with 7 or more years of industry experience.
At least 10 years of experience in a regulated GMP testing laboratory, including 7 years in an independent technical role.
Substantial experience and scientific/technical expertise in one or more relevant areas, such as protein chemistry, microbiological methods, seedstock testing, environmental or utility monitoring, analytical or microbiological method validation, assay development and troubleshooting, compendial raw-material testing, stability programs, critical reagent and reference qualification, LIMS, or QC equipment and calibration maintenance.
Experience with analytical or microbiological method validation protocols and reports, validation data review, development of method acceptance criteria, and statistical data analysis.
Strong scientific analytical skills and proficiency in Microsoft Word, PowerPoint, and Excel.
Strong understanding of statistical tools used in process and method validation data analysis.
Familiarity with GMPs and Quality System Regulations.
Good planning and organizational skills, effective time management and prioritization, initiative in solving problems, and judgment about when to seek assistance.
Ability to work ethically and ensure compliance with company ethics and compliance guidelines.
Must meet the six mission-critical competencies: Customer Focus, Function/Technical Skills, Composure, Intellectual Powerhouse, Presentation Skills, and Approachability.
May be considered through directly related experience or a combination of education, experience, and/or competencies in place of stated requirements.

Responsibilities

Serve as the resident expert for technical issues in the assigned area of expertise.
Select, train, and develop staff in accordance with company policies; mentor and cross-train QC staff to support analyst development and functional depth.
Troubleshoot existing processes, identify causal factors through root-cause analysis, and develop effective solutions.
Write method validation protocols, validation summary reports, and method development reports in the relevant scientific areas.
Evaluate method validation packages for accuracy and compliance with current ICH and Grifols Quality guidelines.
Assist QC management with regulatory and internal inspections and audits, including responses to audit observations.
Drive and execute analytical method development, assay optimization, method validation, and method transfer into QC laboratory testing functions.
Support applicable programs in areas such as reference and critical reagent qualification, antigen and seedstock stability, seedstock manufacturing, equipment and eSystems, LIMS, analytical method validation, DR and CAPA, EH&S, OE/5S/6S, and QC-specific projects.
Assist with planning and executing operational excellence projects, including 5S, Value Stream Mapping, Role Cards, Level and Flow, and standard work.
Comply with site Environmental Health & Safety requirements.
Follow ethical practices and ensure employees adhere to Grifols ethics and compliance guidelines.