QC Scientist

Grifols Shared Services North America, Inc; San Diego (CA); On-site; USD 115,000 - 140,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Life insurance

PTO & paid holidays

401(k) match

Tuition reimbursement

Job summary

Grifols Diagnostic Solutions Inc is seeking a QC Scientist to provide technical leadership in the QC laboratory, specializing in analytical method validation, development, and transfer. You will partner with MS&T, Manufacturing and QA staff to ensure robust testing and regulatory readiness.

Qualified candidates bring 10+ years in GMP labs or a MS with 7+ years, strong HPLC and protein chemistry skills, and a track record of driving process improvements while upholding quality systems.

Qualifications

• PhD/masters with extensive GMP experience in a regulated lab.
• Experience in method development, validation, transfer and troubleshooting.
• Strong knowledge of analytical chemistry in QC environments.
• Experience with ICH guidelines and regulatory expectations.

Responsibilities

• Act as resident expert for technical issues in QC areas.
• Mentor and train staff to enhance skill depth.
• Lead method development, validation and transfer to QC labs.
• Support inspections and respond to audit observations.
• Drive OE projects and maintain compliance with EH&S and QA programs.

Skills

Protein chemistry

HPLC

QC method validation

GMP/QS regulations

Analytical troubleshooting

Biomolecule analysis

Data analysis (statistics)

Education

Biochemistry / Molecular Biology / Immunology degree (BS, +10 yrs) OR MS/PhD with 7+ yrs

Tools

LIMS

Spectroscopy/ELISA

Job description

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.

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, 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

Education:

• Bachelor’s 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 Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s 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 for QC Scientist role based in California, is $115,000 to $140,000 per year. Additionally, the position is eligible to participate in up to 8% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, life insurance, PTO, paid holidays and up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and 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

Learn more about Grifols (https://www.grifols.com/en/what-we-do)

Type: Regular Full-Time