QC Specialist I

Key Responsibilities

• Perform testing of raw materials, intermediates, final products, and stability by following analytical methods.
• Maintain, calibrate, and operate equipment and instruments supporting cell bioassays, Flow Cytometry, ELISA, and PCR assays.
• Track and test products according to stability protocols.
• Work with internal and external resources to maintain the lab in an optimal state.
• Monitor and trend data, complete routine record review of test data and related documents for in-process testing, drug substance, and drug product release. Generate Certificates of Analysis (CoAs) for product release.
• Assist in the preparation of dossiers and data packages for interactions between Kite (Gilead) and regulatory agencies; participate in Pre-Approval Inspections.
• Develop, revise, and review SOPs, qualification/validation protocols, and reports.
• Conduct investigations regarding out-of-specification (OOS) results and manage deviations related to analytical procedures. Provide updates at daily and weekly meetings.
• Monitor GMP systems to ensure compliance with documented policies.
• Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies as appropriate.
• Gather metric information for continuous improvement of areas of responsibility.
• Perform other duties as required.

Basic Qualifications

• BS degree in a scientifically oriented field and at least 2 years related work experience.

OR

• MS degree in a scientifically oriented field and at least 0 years related work experience.

Preferred Qualifications

• At least 2 years of industry experience in a biotech and/or pharmaceutical quality-related role.
• Strong knowledge of GMP, SOPs, and quality control processes.
• Experience identifying, writing, evaluating, and closing OOS investigations.
• Proficient in MS Word, Excel, PowerPoint, and other applications.
• Strong written and verbal communication skills.
• Ability to communicate and work independently with scientific/technical personnel.
• Well-versed in analytical techniques such as Flow Cytometry, ELISA, PCR, and cell bioassays for biopharmaceutical testing.
• Working knowledge of quality systems and regulatory requirements (21 CFR Part 11/210/211).
• Flexibility to work alternate schedules, including weekends, as business needs require.