JOB SUMMARY
The Sr. QA Associate (Auditor) has the primary responsibility for hosting client/regulatory audits that are in conformance with quality processes standards and procedures. Additionally this role has the primary responsibility for creating and executing against the Internal Audit program.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Hosts and performs routine audits which includes support in creation/review of audit agenda management of audit requests and management and oversight of audit reports (and associated responses).
Audits methods sequences set-ups to ensure the conformance and specifications to the clients expectations.
Directly interfaces with quality professionals to coordinate schedules hosting activities and answering frequently asked questions from visitors and auditors regarding the Quality Management System as the QA representative for the site.
Supports and works collaboratively with area leads to implement appropriate CAPAs /audit actions from audits as agreed upon.
Follows up with the required reports and responses ensure timely delivery of documents.
Generates aggregates and organizes data to present to management to demonstrate programs status
May perform other duties and responsibilities as assigned.
JOB QUALIFICATIONS
KNOWLEDGE REQUIREMENTS
Bachelors Degree is a science/ STEM major and/or 3 years of experience working in a regulated life-science (Pharmaceutical aseptic preferred).
Strong understanding of FDAs Six-System Audit Schema
Ability to effectively present information and respond to questions from managers clients customers and other entities.
Ability to define problems collect data establish facts and draw valid conclusions.
Advanced skill to operate a personal computer including using a Windows based operating system and related software.
Ability to write technical and consumer facing correspondence.
Ability to deal with custom situations that are rare and complex.
Ability to read and comprehend technical and scientific documentation such as regulatory guidance documents validation reports and products drug master file.
Strong communication skills and must be able to be articulate with clients and internal stakeholders in all communication methods.
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Jabil including its subsidiaries is an equal opportunity employer and considers qualified applicants for employment without regard to race color religion national origin sex sexual orientation gender identity age disability genetic information veteran status or any other characteristic protected by law.
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Required Experience:
Senior IC
At Jabil we strive to be the most technologically advanced and trusted manufacturing solutions provider.