QC Scientist

Grifols•San Diego, CA

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 Scientist serves as a high-level subject matter expert in one or more areas within 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 role requires expertise in analytical development, qualification, validation, method transfer, comparability, and troubleshooting of test methods used for lot release, stability, in-process, and cleaning testing. The position interacts with Manufacturing Sciences and Technology, Manufacturing, and Quality Control staff, including for training and technology transfer. The Scientist leads and supports analytical method development, assay optimization, validation, and transfer into QC testing functions. They also provide technical guidance and staff development, prepare and review validation documentation, troubleshoot processes, support audits and inspections, and contribute to operational excellence and environmental, health, and safety programs. The role requires a relevant science degree and substantial experience in a regulated GMP testing laboratory, including independent technical work. Work is generally performed in an office environment, with occasional entry into a BioRisk Area and possible exposure to biological fluids and infectious organisms. Personal protective equipment is required in applicable areas. The role may require driving to site locations and occasional travel within the United States. The estimated California pay scale is $115,000 to $140,000 per year, with eligibility to participate in up to 8% of the company bonus pool. Benefits include medical, dental, vision, life insurance, paid time off, paid holidays, a 401(k) match of up to 5%, and tuition reimbursement.

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 scientific and technical expertise in one or more relevant areas, such as protein chemistry methods, microbiological methods, seedstock testing, environmental and utility monitoring, analytical or microbiological method validation, 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, acceptance criteria development, and statistical data analysis.
Assay development and troubleshooting experience in the relevant area of expertise.
Strong scientific analytical skills and proficiency with MS Word, MS PowerPoint, and MS Excel.
Strong understanding of statistical tools used in process and method validation data analysis.
Familiarity with GMPs and Quality System Regulations.
Good planning and organizing 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.
Ability to communicate information and ideas clearly, listen to and understand spoken and written information, interact with others, convey sensitive information to diverse groups, and work with diverse groups to obtain consensus.
Ability to perform the stated occupational demands, including frequent sitting and hand movements; occasional walking, standing, and bending or twisting the neck; and lifting and carrying up to 25 pounds.
Personal protective equipment, including protective eyewear, garments, and gloves, is required when applicable.

Nice To Haves

Directly related experience, education, and/or competencies may be considered in place of stated requirements, depending on the area of assignment.

Responsibilities

Serve as the resident expert for technical issues in the specified 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, method validation summary reports, and method development reports in relevant scientific areas.
Evaluate existing method validation packages for accuracy and compliance with current ICH and Grifols Quality guidelines.
Assist QC management during regulatory or 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 programs and projects in areas including reference and critical reagent qualification; antigen and seedstock stability; seedstock manufacturing; equipment, eSystems, calibration, and maintenance; LIMS; analytical method validation; DR and CAPA; EH&S; OE/5S/6S; and QC-specific projects such as eLab.
Assist with planning and execution of operational excellence projects, including 5S, Value Stream Mapping, Role Cards, Level and Flow, and Standard Work.
Comply with site Environmental Health & Safety requirements.
Promote ethical conduct and ensure employees follow Grifols ethics and compliance guidelines.