QC Specialist I

Responsibilities (include but are not limited to):

• 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 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. Generation of CoAs for product release.
• Assist in the preparation of dossiers and data packages for interactions between Kite ( GILEAD) and Regulatory agencies. Interact with agents from Regulatory agencies and participate in Pre-Approval Inspections.
• Develop, revise and review SOPs, qualification/validation protocols and reports.
• Conduct investigations regarding out of specifications (OOS) results. Address and manage deviations related to analytical procedures. Provide updates at daily and weekly meetings.
• Monitor the GMP systems currently in place to ensure compliance with documented policies.
• Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
• Gather metric information for use in continuous improvement of areas of responsibility.
• Perform other duties as required.

Basic Requirements:

• BS Degree in a scientifically oriented field and 2+ years related work experience
• MS Degree in a scientifically oriented field and 0+ years related work experience

Preferred Requirements:

• 2+ years of industry experience working in a the biotech and/or pharmaceutical industry Quality related role
• Strong knowledge of GMP, SOPs and quality control processes.
• Identifying, writing, evaluating, and closing OOS’s and investigations.
• Proficient in MS Word, Excel, Power Point and other applications.
• Strong written and verbal communication skills.
• Ability to communicate and work independently with scientific/technical personnel
• Well versed in various analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals.
• Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).

Business need may require alternate work schedule, such as weekend coverage as needed.