QC Sr. Analyst

Responsibilities

• Cookbook 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

Requirements

• Substantial (three or more) assay testing experience in one of the main areas listed
• Knowledge of GMP's and Quality System Regulations (QS Regs)
• Good time management, effectively prioritizing tasks for completion
• Work in an ethical manner and ensure employees follow Grifols ethics and compliance guidelines

Qualifications

• Bachelor’s degree in Biochemistry, Molecular Biology, Immunology with 3 years or MS degree in science with 1 plus years

Skills

• Experience in a regulated GMP testing laboratory

Benefits

Includes medical, dental, vision, life insurance, PTO, paid holidays, up to 5% 401(K) match, and tuition reimbursement.

Pay

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.