JOB SUMMARY
The Sr. QA Associate has the primary responsibility for hosting client/regulatory audits that are in conformance with quality processes standards and procedures. Additionally this hole 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 Pii.
Supports and works collaboratively with area lead to implement appropriate CAPAs or audit actions from third-party audits regulatory observations or internal agreed upon actions.
Follows up with the required reports and responses ensure timely delivery of documents..
May perform other duties and responsibilities as assigned.
JOB QUALIFICATIONS
KNOWLEDGE REQUIREMENTS
Bachelors Degree is a science/ STEM major and/or experience working in a regulated life-science.
Strong understanding of FDAs Six-System Audit Schema
Ability to effectively present information and respond to questions from managers clients customers and other entities as it pertains to Piis Systems and Processes.
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 correspondence.
Ability to deal with custom situations with only 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 must be able to be articulate with clients and internal stakeholders in all communication methods.
The pay range for this role is $68800 - $123800. Job-related non-discriminatory factors used to determine the actual offered rate include qualifications and experience geographic location education external market data and consideration of internal equity.As part of the total rewards package Jabil offers benefits to enhance your health wealth and resilient self. These include medical dental and vision insurance plans; paid time off; paid parental leave; company-paid holidays subject to change yearly;401(k) retirement plan; and employee stock purchase plan.BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a e-mail address. Jabil does not request payments for interviews or at any other point during the hiring process. Jabil will not ask for your personal identifying information such as a social security number birth certificate financial institution drivers license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft contact the Federal Bureau of Investigations internet crime hotline () the Federal Trade Commission identity theft hotline () and/or your local police department. Any scam job listings should be reported to whatever website it was posted in.
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
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