Senior Quality Assurance Associate - Audits

Reposted 17 Days Ago
Be an Early Applicant
Hunt Valley, MD, USA
In-Office
69K-124K Annually
Senior level
Hardware
The Role
The Senior Quality Assurance Associate manages client audits, ensures compliance with quality standards, and collaborates on corrective actions. They generate reports and communicate audit findings to management.
Summary Generated by Built In
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. 
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 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.

JOB QUALIFICATIONS
KNOWLEDGE 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.

The pay range for this role is $68,800 - $123,800. 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 jabil.com e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a jabil.com 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, driver’s 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 (www.ic3.gov), the Federal Trade Commission identity theft hotline (www.identitytheft.gov) 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.

 

Accessibility Accommodation  

If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to [email protected] or calling 727-803-7988 with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail or phone number. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to.

 

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Top Skills

Quality Management System
Regulatory Guidance
Windows Operating System
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The Company
Arden, NC
41,000 Employees
Year Founded: 1966

What We Do

Jabil is a product solutions company providing comprehensive design, manufacturing, supply chain and product management services.

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