Senior Quality Assurance Associate - Audits

Jabil • Hunt Valley, MD

11d

About The Position

At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, manufacturing, and supply chain solutions. With over 50 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe. 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.

Requirements

• Bachelor's Degree is a science/ STEM major and/or 3+ years of experience working in a regulated life-science (Pharmaceutical, aseptic preferred).
• Strong understanding of FDA's 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 product's drug master file.
• Strong communication skills and must be able to be articulate with clients and internal stakeholders in all communication methods.

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 client's 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees