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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in Quality Control processes, including method validation, analytical development, and regulatory compliance. Proficient in training and mentoring staff while ensuring adherence to GMP and Quality System Regulations.
Highest-signal resume keywords
Method ValidationAnalytical DevelopmentGMP Testing Laboratory ExperienceStatistical AnalysisTraining and Mentoring
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Method Validation ProtocolsAssay DevelopmentTroubleshooting Test MethodsProtein ChemistryMicrobiological TestingLIMSValidation Data AnalysisReagent QualificationEnvironmental MonitoringStatistical Tools
Soft Skills
Customer FocusComposurePresentation SkillsApproachabilityEffective Communication
Tools & Technologies
MS WordMS PowerPointMS ExcelLIMSELab
Industry Keywords
GMPQuality System RegulationsRoot Cause AnalysisRegulatory ComplianceEnvironmental Health & SafetyQuality ControlAnalytical Method TransferSeed Stock Stability ProgramsCalibrationOE/5S/6S
About the role
Key responsibilities & impact- Provide technical/scientific expertise and analytical leadership within the quality control department
- Serve as a high-level subject matter expert for assigned scientific technical areas in QC laboratories
- Serve as the resident expert for technical issues in the area of expertise
- Select, train, develop, mentor, and cross-train QC staff
- Troubleshoot existing processes, identify causal factors through root cause analysis, and develop problem-resolution strategies
- Write method validation protocols, validation summary reports, and method development reports
- Evaluate method validation packages for accuracy and compliance with current ICH and Grifols Quality guidelines
- Assist QC management with regulatory and internal inspections/audits and audit observation responses
- Drive and execute analytical method development, assay optimization, method validation, and method transfer into QC laboratory testing functions
- Support reference and critical reagent qualification programs
- Support antigen and seed stock stability programs and seed stock manufacturing
- Support equipment, eSystems, calibration, maintenance, LIMS, DR/CAPA, EH&S, OE/5S/6S, and QC-specific projects such as eLab
- Assist with planning and execution of OE projects including 5S, Value Stream Mapping, Role Cards, Level and Flow, and Standard Work
- Interact with MS&T, Manufacturing, and QC staff for training and technology transfer
- Comply with site EH&S requirements
Requirements
What you’ll need- Bachelor’s degree in Biochemistry, Molecular Biology, or Immunology with 10 years of experience, or MS/PhD degree in science with 7+ years of industry experience
- At least 10 years’ experience in a regulated GMP testing laboratory
- 7 years in an independent technical role
- Substantial experience and scientific/technical expertise in one or more specified analytical, microbiological, validation, stability, reagent qualification, LIMS, or QC equipment areas
- Experience with analytical development, qualification, validation, method transfer, comparability, and troubleshooting of test methods
- Experience with protein chemistry, microbiological, seedstock, environmental/utility/facility monitoring, or compendial testing methods
- Experience writing and reviewing method validation protocols, reports, validation data, acceptance criteria, and statistical analyses
- Assay development and troubleshooting experience
- Proficiency in MS Word, MS PowerPoint, and MS Excel
- Strong understanding of statistical tools for process/method validation data analysis
- Familiarity with GMPs and Quality System Regulations
- Must work ethically and ensure compliance with Grifols ethics and compliance guidelines
- Must meet six mission-critical competencies: Customer Focus, Function/Technical Skills, Composure, Intellectual Powerhouse, Presentation Skills, and Approachability
- Ability to comply with site Environmental Health & Safety requirements
- Ability to use personal protective equipment and work with potential exposure to biological fluids and infectious organisms
- Ability to lift and carry up to 25 lbs
- Ability to communicate effectively, listen, understand information, and work with diverse groups to obtain consensus
- Occasional travel within the United States may be required
- Directly related experience or a combination of directly related education, experience, and/or competencies may be considered in place of stated requirements
Benefits
Comp & perks- Up to 8% of the company bonus pool
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- PTO
- Paid holidays
- Up to 5% 401(K) match
- Tuition reimbursement
- Opportunities for professional growth and career progression
- Family-like culture