QC Analytical Specialist II

Gilead Sciences•Frederick, MD

About The Position

Kite is seeking a QC Analytical Specialist II to perform analytical testing and support quality control activities for biopharmaceutical products. The position performs testing of raw materials, intermediates, and final products using cell-based bioassays, flow cytometry, ELISA, and qPCR assays. It also supports laboratory readiness, data review and trending, product release documentation, instrument maintenance, investigations, and GMP compliance. The listed shift runs Saturday at 11:30 PM through Wednesday at 10:00 AM. Potential shifts may also run Sunday–Wednesday or Wednesday–Saturday, and business needs may require an alternate work schedule. The position is based at Kite, a biopharmaceutical company focused on developing cancer immunotherapies.

Requirements

Master’s degree; or bachelor’s degree with at least 3 years of experience in biotechnology or a related field and Quality Control experience; or associate degree with at least 5 years of such experience; or high school degree with at least 7 years of such experience.
Thorough knowledge of GMP, SOPs, and quality control processes.
Experience identifying, writing, evaluating, and closing OOS investigations.
Proficiency in Microsoft Word, Excel, PowerPoint, and other applications.
Strong written and verbal communication skills.
Ability to communicate and work independently with scientific and technical personnel.
Knowledge of analytical techniques such as flow cytometry, ELISA, PCR, and cell-based bioassays, and other applicable methods for biopharmaceutical testing.
Working knowledge of quality systems and regulatory requirements, including 21 CFR Parts 11, 210, and 211.

Nice To Haves

Experience in the biotechnology and/or pharmaceutical industry.

Responsibilities

Perform analytical testing of raw materials, intermediates, and final products using cell-based bioassays, flow cytometry, ELISA, and qPCR assays.
Work with internal and external resources to maintain the laboratory in an optimal state.
Assist with monitoring and trending data and complete routine reviews of test data and related in-process, drug substance, and drug product release documents.
Supply information to support generation of Certificates of Analysis (CoAs) for product release.
Maintain laboratory instruments, including calibration and routine maintenance.
Author or revise SOPs, qualification and validation protocols, and reports.
Assist with laboratory investigations regarding out-of-specification (OOS) results.
Participate in determining root causes for 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 regulatory submissions, as appropriate.
Gather metric information for continuous improvement in areas of responsibility.
Perform other duties as required.