Grifols Diagnostic Solutions in Emeryville, CA is seeking a Senior QC Analyst. The Senior QC Analyst will use experience in all analytical assay method training to coordinate and perform critical material qualification and maintenance and/or other projects that are in addition to typical release, reference/reagent qualification and/or stability testing. To provide expertise to their designated QC group, and to accurately assess the purity, potency, efficacy, and other performance characteristics for the purpose of supporting both manufacturing and quality assurance in the production, release, and monitoring of established product lines.
To qualify for the Senior QC Analyst role, we are seeking individuals with at least a Bachelor's degree in Biochemistry, Molecular Biology, Immunology with 3 years in a regulated GMP testing laboratory or MS Degree in Science with 1 plus years.
Responsibilities: - Coordinate and perform assays for their designated laboratory
- Routine in-process, final product (antigens) protein chemistry testing for release
- Routine in-process, final product (antigens) microbiological testing for release of product Routine testing for release of Raw Materials
- Routine testing for release of Seed Stock
- Antigen Stability, reference/reagent qualification testing
- Seedstock Stability testing
- Cleaning and or Process Validation testing
- Analytical Method Validation testing
- Product/Method development testing
- Use experience and method expertise to conduct troubleshooting
- May be assigned to assist with OOS Investigations
- May be assigned to work independently on Validation, and Technical studies
- May be assigned to assist with the planning and execution of OE projects
- May be assigned to train staff on test methods
- Comply Site Environmental Health & Safety (EH&S) requirements
Knowledge, Skills, and Abilities: - Must have substantial (three or more) assay testing experience in one 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 complendial test methods
- Assay trouble shooting experience in their expert area
- Pharmacoepeial (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
- Proficient in MS Word, MS Powerpoint and MS Excel software
- Must be familiar with GMP's and Quality System Regulations (QS Regs)
- Must have good time management, effectively prioritizing tasks for completion
- Individual must work in an ethical manner and ensure employees follow Grifols ethics and compliance guidelines.
- Must meet the two (2) mission critical competencies: 1) Customer Focus 2)Function/Technical Skills
Education: Bachelor's degree in Biochemistry, Molecular Biology, Immunology with 3 years or MS degree in science with 1 plus years.
Experience: At least 3 years' experience in a regulated GMP testing laboratory
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 typically requires an Associate's degree plus 2 years of experience, an equivalent could include 4 years of experience or a bachelor's degree.
The estimated pay scale for Senior QC Analyst role based in Emeryville, California, is $38.58 per hour to $48.23 per hour. Additionally, the position is eligible to participate in up to 5% 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.
Location: NORTH AMERICA : USA : CA-Emeryville:USEMV - Emeryville CA-HeadquartersLearn more about Grifols
