QA Specialist III

Gilead Sciences•El Segundo, CA

2d•$107,185 - $138,710

About The Position

The QA Specialist III provides quality assurance oversight and approval for moderately to significantly complex or novel deviation, out-of-specification (OOS), change control, corrective and preventive action (CAPA), and effectiveness verification (EV) records. The role ensures records are properly initiated, investigated, and resolved within established timelines, and that deviations are escalated according to procedures. It also supports resolution of product, manufacturing, environmental, facility, equipment, and material issues, and identifies compliant efficiencies in deviation and CAPA processes at TCF03. Additional duties may be assigned, and duties may be delegated to qualified designated deputies as needed. The role calls for proficiency in GMP and/or GLP, QA principles and industry standards, FDA and EMEA standards and quality systems, and their interfaces with manufacturing, distribution, and maintenance. It also involves use of Six Sigma, Lean, and root-cause analysis tools, along with auditing, investigations, and report writing.

Requirements

Demonstrated proficiency in GMP and/or GLP.
Demonstrated proficiency in applying QA principles, concepts, industry practices, and standards.
Thorough knowledge of FDA and EMEA standards, quality systems, and interfaces with manufacturing, distribution, and maintenance.
Strong knowledge of Six Sigma, Lean, and root-cause analysis tools for identifying and correcting deviations.
Demonstrated auditing, investigation, and report-writing skills.
Strong verbal, technical writing, and interpersonal skills.
Proficiency in Microsoft Office applications.
One of the following education and experience combinations, including auditing experience: a master’s degree and 3 or more years of relevant GMP or regulated-industry experience; a bachelor’s degree and 5 or more years; or a high school diploma and 8 or more years.

Responsibilities

Provide QA oversight and approval of moderately to significantly complex or novel deviation, OOS, and change control records.
Ensure records are properly initiated, investigated, and resolved according to established timelines.
Provide QA oversight and approval of moderately to significantly complex or novel CAPA and EV records.
Ensure CAPAs are initiated and resolved in a timely manner.
Ensure deviations are escalated according to procedures.
Identify compliant efficiencies in the execution of deviation and CAPA processes at TCF03.
Provide QA support in resolving in-process product, final product, manufacturing, environmental, facility, equipment, and material issues.
Perform additional duties as assigned; duties may be delegated to qualified designated deputies as needed.