QC Scientist - Performance

GRIFOLS, S.A.•San Diego, CA

1d•$96,238 - $120,298•Onsite

About The Position

Grifols Diagnostic Solutions Inc is seeking a QC Scientist. The Scientist will provide technical/scientific expertise and analytical leadership within the quality control department. The Scientist will serve as premier high level subject matter expert for defined area(s) of scientific technical expertise within the Grifols Diagnostic Solutions Quality Control Laboratories which consist of: Method Validation, Antigen Release and Stability, QC Raw Materials (QCRM), QC Microbial (including seedstock) and QC Equipment/eSystems programs. The Scientist should have expertise in analytical development, qualification, validation, method transfer, comparability, and troubleshooting of test methods used for lot release, stability, in-process and cleaning methods. This role will interact with Manufacturing Sciences and Technology (MS&T), Manufacturing, Quality Control staff for training, technology transfer. To qualify for this role, we are seeking individuals with at least a Bachelors degree in Biochemistry, Molecular Biology, Immunology along with 10 years of industry experience. For those that have a Masters degree or PhD in Science, we’re targeting 7 plus years of industry experience.

Requirements

Must have substantial experience and scientific/technical expertise in one or more of the main areas listed: Protein chemistry methods such as Lowry, Bradford, BCA, SDS-PAGE, Western Blot, HPLC, Amino Acid Analysis, ELISA's and in vitro diagnostic test kits. Microbiological methods such as Microbial Limits Test (bioburden), Sterility, Endotoxin, TOC, Microbial Identification, Contamination testing and Growth Promotion. Bacterial and Yeast Seedstocks testing methods such as Microscopic examination, viability, contamination, purity and phenotype testing, DNA Plasmid isolation and restriction digest testing. Environmental/Utility/facility Monitoring testing such as Sampling of and testing of manufacturing water by membrane filtration, viable and non-viable particulate testing of facilities and utilities, viable (surface) monitoring of manufacturing facilities, personnel and biological hoods, moisture and oil content testing of compressed gases Analytical/Microbiological Method Validation testing such as Bacteriosis and Fungistasis, linearity, specificity and robustness tests in protein chemistry, microbiology or compendial test methods Analytical/Microbiological Method Validation protocols, reports, review of validation data, development of method acceptance criteria, statistical data analysis
Assay Development and troubleshooting experience in their expert area(s)
Pharmacopeial (compendial) test methods for Raw Materials such as, but not limited to; melting point, loss on drying, color and appearance, identity by FTIR, heavy metals, arsenic, residual solvents, chloride, sulphate, insoluble matter
Stability programs
Critical reagent and reference qualification programs
LIMS
QC Equipment/calibration maintenance programs
Strong scientific analytical skills, proficient in MS Word, MS PowerPoint and MS Excel software.
Strong understanding of Statistical tools used in Process/Method Validation Data analysis
Must be familiar with GMP's and Quality System Regulations (QS Regs).
Must have good planning and organizing skills, manage time effectively by prioritizing tasks, taking the initiative to solve problems quickly, and knowing when to obtain assistance.
Individual must work in an ethical manner and ensure employees follow Grifols ethics and compliance guidelines.
Must meet the Six (6) mission critical competencies: 1) Customer Focus 2) Function/Technical Skills 3) Composure 4) Intellectual Powerhouse 5) Presentation Skills 6) Approachability
Bachelor’s degree in Biochemistry, Molecular Biology, Immunology with 10 years or MS/PhD degree in science with 7 plus years.
At least 10 years’ experience in a regulated GMP testing laboratory with 7 years in an independent technical role.

Responsibilities

Serves as resident expert for technical issues in specified area of expertise/focus.
Select, train and develop staff so that they realize their full potential and work in conformance to company policies
Provide mentoring and cross-training to other QC staff and to support analyst development and functional depth.
Troubleshoot problems in existing processes, identify and isolate causal factors through effective root cause analysis techniques. and proactively innovate new and effective strategies for problem resolution solutions
Write method validation protocols, method validation summary reports, and method development reports in their scientific areas.
Evaluate existing method validation packages for accuracy and compliance with current ICH and Grifols Quality guidelines.
Assist Quality Control department management during inspections/audits (regulatory or internal) and audit observation responses
Utilize expertise to drive and execute analytical method development, assay optimization, method validation and method transfer into the QC department in laboratory testing functions in one or more of the following areas: Reference qualification program Critical Reagent qualification program Antigen stability program Seed Stock stability program Seed Stock manufacturing program Equipment/eSystems/calibration/maintenance programs LIMS Analytical Method Validation program DR and CAPA program EH&S program OE/5S/6S program QC specific projects (such as eLab)
Assist with the planning and execution of OE projects such as 5S, Value Stream Mapping (VSM), “Role Cards”, “Level and Flow”, “Standard” work
Comply Site Environmental Health & Safety (EH&S) requirements