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Would you like to join an international team working to improve the future of healthcare Do you want to enhance the lives of millions of people Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop produce and market innovative medicines solutions and services in more than 110 countries and regions. |
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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.
Primary Responsibilities for Role:
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
Knowledge Skills and Abilities:
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 ELISAs 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 GMPs 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
Education:
Bachelors degree in Biochemistry Molecular Biology Immunology with 10 years or MS/PhD degree in science with 7 plus years industry experience.
Experience: At least 10 years experience in a regulated GMP testing laboratory with 7 years in an independent technical role.
Equivalency:
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 Bachelors degree plus 4 years of experience an equivalency could include 8 years of experience an Associates degree with 6 years of experience or a Masters degree with 2 years of experience.
Occupational Demands: Work is performed in an office environment with exposure to electrical office equipment. May occasionally enter BioRisk Area. Exposure to biological fluids with potential exposure to infectious organisms. Personal protective equipment required such as protective eyewear garments and gloves. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast simple movements of the fingers hands and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Drives: varies may or may be required to frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.
The estimated pay scale forQC Scientist role based inCalifornia is $115000 to $140000per year. Additionally the position is eligible to participate in up to 8% of thecompanybonus pool. We offer a wide variety of benefits including but not limited to: Medical Dental Visionlife insurancePTOpaid holidays andup to 5% 401(K) match and tuition reimbursement. Final compensation packages willultimately dependon education experience skillset knowledge where the role is performed internalequityand market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909 Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years and you can grow with us!
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active nonexpired Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy childbirth or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws including but not limited to the California Fair Chance Act the Los Angeles County Fair Chance Ordinance for Employers and the City of Los Angeles Fair Chance Initiative for Hiring Ordinance.
California Personnel Privacy Policy and Notice at Collection
Location:NORTH AMERICA : USA : CA-San Diego:USSDW - San Diego CA - Willow Ct Mfg
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