Senior Quality Assurance Associate

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 role has the primary responsibility for creating and executing against the Internal Audit program.

• 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 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.

• Bachelor's Degree is a science/ STEM major and/or experience working in a regulated life-science.
• 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 as it pertains to Pii's 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 product's drug master file.
• Strong communication skills, must be able to be articulate with clients and internal stakeholders in all communication methods.

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. The pay range for this role is $68,800 - $123,800.