QA Specialist II

Job Description

Job Summary:

• We are seeking a highly motivated individual to join us as a Quality Assurance Specialist II.
• In this role you will be responsible for executing a variety of Quality activities to ensure compliance with applicable quality objectives and regulatory requirements.
• You will be located at our El Segundo, CA site and report into the Sr. Manager of Quality Assurance Operations.
• The standard work week for this position is M-F, however weekend/night work will be required during manufacturing campaigns to support process operations

Duties and Responsibilities:

• To provide QA oversight and approval of deviation, OOS, and change control records that have moderate to significant levels of complexity and/or novelty.
• Ensure records are properly initiated, investigated and resolved in accordance with established timelines.
• To provide QA oversight and approval of CAPA and EV records that have moderate to significant levels of complexity and/or novelty.
• Ensure CAPAs are initiated and resolved in a timely manner.
• Ensure escalation of deviations per procedures
• Identify efficiencies in the execution of the Deviation ad CAPA processes at TCF03 in a compliant manner
• Provide QA support resolving in-process product, final product, manufacturing, environmental, facility and equipment and material issues.

Basic Qualifications:

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

Preferred Qualifications:

• Quality Control background in Analytical, Virological, and Microbiological testing.
• Working knowledge and ability to apply GMPs in conformance to U.S. and EU standards.
• Ability to effectively negotiate and build collaboration amongst individuals.
• Proficient in MS Word, Excel, Power Point and other applications.
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.