Quality Assurance Auditor Jobs in Delaware
Quality Assurance Auditor jobs in Delaware are concentrated in the pharmaceutical, chemical, and financial services industries, with demand at every level from entry-level inspector to senior compliance lead. Most openings are in Wilmington, Newark, and Dover, where established employers like DuPont, AstraZeneca, and JPMorgan Chase maintain significant operations. The most consistent demand is for auditors with expertise in GMP compliance, FDA regulatory standards, and internal financial controls. Scan the live roles below and apply to whichever ones fit.
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Showing 5 of 15+ Quality Assurance Auditor jobs
Company Overview
WuXi STA is building new pharmaceutical manufacturing capability and is establishing the quality systems that will support it. For more information, see:
New manufacturing facility announcement
About the company
Responsibilities:The Quality Assurance Specialist is a fully qualified quality professional who provides independent, on-the-floor quality assurance support to manufacturing and operations while the site’s GMP quality system is being established. This is a build role rather than a maintenance role: the Specialist helps stand up the quality processes, systems, and documentation required for Oral Solid Dosage (OSD) and Sterile drug-product manufacturing—including aseptic processing and drug-substance operations—and ensures compliance with applicable GMP regulations and health-authority expectations.
Working with limited precedent, the Specialist exercises independent judgment to resolve quality issues of diverse scope, advises operations and cross-functional partners, and helps embed a “Right First Time” culture as the site progresses toward routine GMP operations. Work is performed independently and reviewed at critical points.
Key Responsibilities
- Provide independent on-the-floor quality assurance support to manufacturing and operations, including real-time batch record review and timely disposition of quality events during production.
- Help establish and document the site quality management system (QMS), authoring and improving SOPs, work instructions, and job aids for sterile/aseptic and drug-product operations to meet FDA, EMA, and other applicable health-authority requirements.
- Own quality events end to end—deviations, investigations, root-cause analysis, CAPAs, change controls, and effectiveness checks—applying structured problem-solving to events of diverse scope and limited precedent.
- Review commissioning, qualification, and validation (CQV) documentation, including URS, FAT/SAT, turnover packages, IQ/OQ/PQ, and process validation.
- Lead readiness inspections of manufacturing areas, equipment, computerized systems, and processes to identify and mitigate quality risks prior to operational start-up.
- Support new product introduction (NPI) and technology-transfer activities, providing quality oversight of batch records, bills of materials, and related documentation to enable right-first-time execution.
- Design and deliver quality and GMP training, and coach operations and quality colleagues to build capability and a sustained “Right First Time” culture during this formative period.
- Serve as a quality subject-matter expert for internal, client, and regulatory inspections, and advise stakeholders toward sound and compliant decisions.
- Ensure complete, accurate, and contemporaneous records in accordance with Good Documentation Practices and data-integrity (ALCOA+) principles, including appropriate use of electronic QMS and document-management systems and other validated digital quality tools.
- Partners across manufacturing, engineering, and validation functions to integrate quality requirements into daily operations.
- Bachelor’s degree in scientific or engineering discipline, or an equivalent combination of education and directly relevant experience.
- Approximately five years of pharmaceutical or biopharmaceutical quality assurance experience, or an equivalent combination of education and directly relevant experience, including hands-on time in a GMP manufacturing environment.
- Experience supporting a greenfield site or new-facility start-up and standing up QMS processes from the ground up, or experience with New Product Introduction (NPI).
- Experience working in a multiproduct pharmaceutical manufacturing facility, including managing differing customer requirements and the controls used to prevent cross-contamination between products.
- Demonstrated, hands-on understanding of both manufacturing/production operations and quality assurance.
- Direct experience with sterile drug-product manufacturing and aseptic processing in a GMP setting.
- Demonstrated ownership of core QMS elements—deviations, investigations, root-cause analysis, CAPA, and change control—including the ability to explain the rationale and compliance basis behind each.
- Working knowledge of applicable GMP regulations and ICH guidelines, and the ability to apply them to operational decisions.
- Strong Good Documentation Practices and data-integrity (ALCOA+) discipline.
- Experience operating within an electronic quality and/or document management system.
- Excellent written and verbal communication, with the ability to influence and align stakeholders across functions and levels.
- Ability to work independently with limited precedent, exercising sound judgment and seeking review at critical decision points.Experience with electronic QMS / document-management platforms such as Veeva Vault and SAP.
- Experience supporting audits and inspections, including backroom management and subject-matter-expert preparation.
- Quality or auditing certification (for example, ASQ CQA, CQE, or CMQ/OE).
- Familiarity with risk-management tools (for example, FMEA) and statistical process control concepts.
- Composed and credible in client-facing and inspection settings.
- Familiarity with AI regulations to ensure the data is secure and understanding of the data-integrity and confidentiality risks associated with unvalidated AI tools.
- Key Competencies
- Right First Time mindset: drives quality at the source and coaches others to do the same.
- Collaborative, organized, and systematic; brings structure to ambiguous and evolving situations.
- Clear communicator who adapts to both technical and non-technical audiences.
- Comfortable contributing in a dynamic, build-stage environment.
Work Environment and Physical Requirements
- Work in a GMP manufacturing environment, including cleanroom and classified areas that require gowning and adherence to aseptic behaviors.
- Periods of standing, walking, and on-floor presence during production.
- Occasional travel for audits.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
Company Overview
WuXi STA is building new pharmaceutical manufacturing capability and is establishing the quality systems that will support it. For more information, see:
New manufacturing facility announcement
About the company
Responsibilities:The Quality Assurance Specialist is a fully qualified quality professional who provides independent, on-the-floor quality assurance support to manufacturing and operations while the site’s GMP quality system is being established. This is a build role rather than a maintenance role: the Specialist helps stand up the quality processes, systems, and documentation required for Oral Solid Dosage (OSD) and Sterile drug-product manufacturing—including aseptic processing and drug-substance operations—and ensures compliance with applicable GMP regulations and health-authority expectations.
Working with limited precedent, the Specialist exercises independent judgment to resolve quality issues of diverse scope, advises operations and cross-functional partners, and helps embed a “Right First Time” culture as the site progresses toward routine GMP operations. Work is performed independently and reviewed at critical points.
Key Responsibilities
- Provide independent on-the-floor quality assurance support to manufacturing and operations, including real-time batch record review and timely disposition of quality events during production.
- Help establish and document the site quality management system (QMS), authoring and improving SOPs, work instructions, and job aids for sterile/aseptic and drug-product operations to meet FDA, EMA, and other applicable health-authority requirements.
- Own quality events end to end—deviations, investigations, root-cause analysis, CAPAs, change controls, and effectiveness checks—applying structured problem-solving to events of diverse scope and limited precedent.
- Review commissioning, qualification, and validation (CQV) documentation, including URS, FAT/SAT, turnover packages, IQ/OQ/PQ, and process validation.
- Lead readiness inspections of manufacturing areas, equipment, computerized systems, and processes to identify and mitigate quality risks prior to operational start-up.
- Support new product introduction (NPI) and technology-transfer activities, providing quality oversight of batch records, bills of materials, and related documentation to enable right-first-time execution.
- Design and deliver quality and GMP training, and coach operations and quality colleagues to build capability and a sustained “Right First Time” culture during this formative period.
- Serve as a quality subject-matter expert for internal, client, and regulatory inspections, and advise stakeholders toward sound and compliant decisions.
- Ensure complete, accurate, and contemporaneous records in accordance with Good Documentation Practices and data-integrity (ALCOA+) principles, including appropriate use of electronic QMS and document-management systems and other validated digital quality tools.
- Partners across manufacturing, engineering, and validation functions to integrate quality requirements into daily operations.
- Bachelor’s degree in scientific or engineering discipline, or an equivalent combination of education and directly relevant experience.
- Approximately five years of pharmaceutical or biopharmaceutical quality assurance experience, or an equivalent combination of education and directly relevant experience, including hands-on time in a GMP manufacturing environment.
- Experience supporting a greenfield site or new-facility start-up and standing up QMS processes from the ground up, or experience with New Product Introduction (NPI).
- Experience working in a multiproduct pharmaceutical manufacturing facility, including managing differing customer requirements and the controls used to prevent cross-contamination between products.
- Demonstrated, hands-on understanding of both manufacturing/production operations and quality assurance.
- Direct experience with sterile drug-product manufacturing and aseptic processing in a GMP setting.
- Demonstrated ownership of core QMS elements—deviations, investigations, root-cause analysis, CAPA, and change control—including the ability to explain the rationale and compliance basis behind each.
- Working knowledge of applicable GMP regulations and ICH guidelines, and the ability to apply them to operational decisions.
- Strong Good Documentation Practices and data-integrity (ALCOA+) discipline.
- Experience operating within an electronic quality and/or document management system.
- Excellent written and verbal communication, with the ability to influence and align stakeholders across functions and levels.
- Ability to work independently with limited precedent, exercising sound judgment and seeking review at critical decision points.Experience with electronic QMS / document-management platforms such as Veeva Vault and SAP.
- Experience supporting audits and inspections, including backroom management and subject-matter-expert preparation.
- Quality or auditing certification (for example, ASQ CQA, CQE, or CMQ/OE).
- Familiarity with risk-management tools (for example, FMEA) and statistical process control concepts.
- Composed and credible in client-facing and inspection settings.
- Familiarity with AI regulations to ensure the data is secure and understanding of the data-integrity and confidentiality risks associated with unvalidated AI tools.
- Key Competencies
- Right First Time mindset: drives quality at the source and coaches others to do the same.
- Collaborative, organized, and systematic; brings structure to ambiguous and evolving situations.
- Clear communicator who adapts to both technical and non-technical audiences.
- Comfortable contributing in a dynamic, build-stage environment.
Work Environment and Physical Requirements
- Work in a GMP manufacturing environment, including cleanroom and classified areas that require gowning and adherence to aseptic behaviors.
- Periods of standing, walking, and on-floor presence during production.
- Occasional travel for audits.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
See All 15 Quality Assurance Auditor Jobs in Delaware
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Find JobsQuality Assurance Auditor Jobs by City in Delaware
Where Delaware roles are concentrated, by current openings.
Quality Assurance Auditor Job Market in Delaware
A snapshot from current Delaware openings, updated as new roles post.
Who's Hiring
- Telus2
- WuXi AppTec2
- VitalCore Health Strategies2
- Perdue1
- Hologic1
Top Industries Hiring
- Technology & Software2
- Fintech1
- Food & Beverage1
- Medical Devices1
- Science & Research1
What Delaware Employers Look For
The qualifications that appear most often in quality assurance auditor jobs across Delaware.
- Bachelor's degree in chemistry, life sciences, engineering, or a related field required
- Working knowledge of FDA regulations, GMP standards, or ISO quality frameworks
- Experience conducting internal audits and preparing formal audit reports and documentation
- Familiarity with quality management systems such as SAP, MasterControl, or TrackWise
- Strong written communication skills for drafting corrective action plans and compliance summaries
- Relevant certification such as ASQ Certified Quality Auditor preferred by many Delaware employers
Quality Assurance Auditor Jobs in Delaware: Frequently Asked Questions
How do you become a quality assurance auditor in Delaware?
Most quality assurance auditor roles in Delaware do not require a state-issued license, but employers consistently expect a bachelor's degree in a relevant field alongside demonstrated audit experience. Candidates targeting pharmaceutical or chemical employers benefit from obtaining the ASQ Certified Quality Auditor credential, which signals competency in audit planning and regulatory compliance. Entry into Delaware's pharmaceutical sector often begins in quality control technician or laboratory analyst roles before moving into auditing.
How much do quality assurance auditors make in Delaware?
Quality assurance auditors in Delaware earn a median of about $91,050 a year, based on May 2025 Bureau of Labor Statistics wage data, ranging from around $51,930 for the lowest 10% to over $137,540 for the top 10%. Pay rises with experience, specialty, and employer.
Which companies hire quality assurance auditors in Delaware?
Delaware quality assurance auditor roles are posted by Telus, WuXi AppTec, and VitalCore Health Strategies and others right now, based on current listings on Migrate Mate as of July 2026. Delaware's concentration of pharmaceutical manufacturers, specialty chemical companies, and large financial institutions makes it one of the more active states for quality and compliance auditing roles.
Which Delaware cities have the most quality assurance auditor jobs?
Newark, Wilmington, and Middletown have the most quality assurance auditor openings in Delaware. Wilmington drives most of the volume because of its dense concentration of financial services firms and pharmaceutical company offices, while Newark and Dover attract openings tied to manufacturing operations and state government compliance functions in those areas.
Are there remote quality assurance auditor jobs in Delaware?
Yes, and more than many might expect for this field. About 29% of quality assurance auditor openings tied to Delaware are remote or hybrid as of July 2026, reflecting that financial and regulatory compliance audit work is more desk-based than hands-on manufacturing QA roles. Documentation review, supplier audits, and internal compliance functions are the parts of the role most likely to be performed fully remotely.
How can I get hired as a quality assurance auditor in Delaware with little or no experience?
The most realistic entry path is a quality control technician or laboratory analyst role at one of Delaware's pharmaceutical or chemical manufacturers, which builds the inspection and documentation skills auditors use daily. Employers like AstraZeneca and Incyte have historically hired into structured quality associate programs for candidates with relevant degrees but limited audit experience. Earning the ASQ Certified Quality Improvement Associate credential before applying gives entry-level candidates a measurable edge in Delaware's competitive pharmaceutical hiring market.
Where can I find and apply to quality assurance auditor jobs in Delaware?
You can find and apply to quality assurance auditor jobs in Delaware on Migrate Mate, which lists current openings across Wilmington, Newark, Dover, and the surrounding areas. Search the listings, find roles that match your background and preferred industry, and apply directly to the ones that fit.
See All 15 Quality Assurance Auditor Jobs in Delaware
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