QA Specialist - II

LancesoftEl Segundo, CA

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Overview

Remote

On-site

Job Description

Location: El Segundo, CA

Job DescriptionWe 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

Key Responsibilities (include but are not limited to):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 proceduresIdentify efficiencies in the execution of the Deviation ad CAPA processes at TCF03 in a compliant mannerProvide 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.

Basic Qualifications:

Master s Degree and ORBachelor s Degree and 2+ years experience in the biological sciences or related field ORAA Degree and 4+ years experience in the biological sciences or related field ORHigh School Degree and 5+ years experience in the biological sciences or related field

Preferred Qualifications:Quality Control background in Analytical, Virological, and Microbiological testingWorking knowledge and ability to apply GMPs in conformance to U.S. And EU standardsAbility to effectively negotiate and build collaboration amongst individualsProficient in MS Word, Excel, Power Point and other applications.Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environmentComfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities

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FAQs About QA Specialist - II Jobs at Lancesoft

What is the work location for this position at Lancesoft?

This job at Lancesoft is located in El Segundo, CA, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.

What pay range can candidates expect for this role at Lancesoft?

Candidates can expect a pay range of $44.24.

What employment applies to this position at Lancesoft?

The employer has not provided this information. This may be discussed during the hiring process.

What is the process to apply for this position at Lancesoft?

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