QA Specialist - II

This role is with a biotech client that researches, develops, and commercializes antiviral drugs for HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.

About the role

We are seeking a highly motivated Quality Assurance Specialist II to execute a variety of Quality activities ensuring compliance with applicable quality objectives and regulatory requirements. This is a temporary, onsite assignment located in El Segundo, CA, reporting to the Sr. Manager of Quality Assurance Operations. The standard work week is Monday to Friday, with weekend and night work required during manufacturing campaigns.

Responsibilities

• Provide QA oversight and approval of deviation, out-of-specification (OOS), and change control records with moderate to significant complexity and/or novelty. Ensure records are properly initiated, investigated, and resolved within established timelines.
• Provide QA oversight and approval of Corrective and Preventive Action (CAPA) and Event (EV) records with moderate to significant complexity and/or novelty. Ensure CAPAs are initiated and resolved in a timely manner.
• Escalate deviations per procedures.
• Identify efficiencies in the execution of the Deviation and CAPA processes at TCF03 in a compliant manner.
• Provide QA support for resolving in-process product, final product, manufacturing, environmental, facility, equipment, and material issues.
• Perform additional duties as assigned, which may be delegated to designated deputies of satisfactory qualification level.

Requirements

• Master’s Degree, or
• Bachelor’s Degree and 2+ years of experience in the biological sciences or related field, or
• Associate’s Degree and 4+ years of experience in the biological sciences or related field, or
• High School Degree and 5+ years of experience in the biological sciences or related field.

Skills

• Quality Control background in Analytical, Virological, and Microbiological testing (preferred).
• Working knowledge and ability to apply Good Manufacturing Practices (GMPs) in conformance to U.S. and EU standards.
• Ability to effectively negotiate and build collaboration among individuals.
• Proficient in MS Word, Excel, PowerPoint, and other applications.
• Excellent interpersonal, verbal, and written communication skills.
• Comfortable in a fast-paced, small-company environment with the ability to adjust workload based on changing priorities.

Pay

$43.00 per hour

Schedule

7-month temporary assignment, onsite in El Segundo, CA. Standard work week is Monday to Friday, with weekend and night work required during manufacturing campaigns.