Our client, a Biopharmaceutical company, is looking for a QA Specialist – II for their El Segundo, CA location.
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.
Additional duties as assigned.
These duties can be delegated to designated deputies of a satisfactory qualification level as needed.
Requirements:
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
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