ZipRecruiter

Log In

1

Quality Assurance In Pharmaceutical Jobs in Delaware

Katalyst CRO

Quality Assurance Engineer

Newark, DE · On-site

... in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide. Founded in , the company is headquartered in South Plainfield ...

MSD

Senior Specialist, Quality Assurance

Wilmington, DE · On-site

$80K - $110K/yr

Min 5 years of experience in regulated pharmaceutical manufacturing industry. * At least 3 years of ... Assurance (QA), System Validation Current Employees apply HERE Current Contingent Workers apply ...

The Summit

Quality Assurance Nurse

Hockessin, DE · On-site

$85K/yr

In this role, you will focus on quality assurance initiatives , working closely with our care teams to monitor, evaluate, and enhance resident well-being. If you are committed to excellence in senior ...

The Summit

Quality Assurance Nurse

Hockessin, DE · On-site

$85K/yr

In this role, you will focus on quality assurance initiatives , working closely with our care teams to monitor, evaluate, and enhance resident well-being. If you are committed to excellence in senior ...

The Summit

Quality Assurance Nurse

Hockessin, DE

$85K/yr

In this role, you will focus on quality assurance initiatives , working closely with our care teams to monitor, evaluate, and enhance resident well-being. If you are committed to excellence in senior ...

THE SUMMIT

Quality Assurance Nurse

Hockessin, DE · On-site

$85K/yr

In this role, you will focus on quality assurance initiatives , working closely with our care teams to monitor, evaluate, and enhance resident well-being. If you are committed to excellence in senior ...

THE SUMMIT

Quality Assurance Nurse

Hockessin, DE

$85K/yr

In this role, you will focus on quality assurance initiatives , working closely with our care teams to monitor, evaluate, and enhance resident well-being. If you are committed to excellence in senior ...

The Summit

Quality Assurance Nurse

Hockessin, DE

In this role, you will focus on quality assurance initiatives , working closely with our care teams to monitor, evaluate, and enhance resident well-being. If you are committed to excellence in senior ...

The Summit

Quality Assurance Nurse

Hockessin, DE · On-site

$85K/yr

In this role, you will focus on quality assurance initiatives , working closely with our care teams to monitor, evaluate, and enhance resident well-being. If you are committed to excellence in senior ...

KBR, Inc.

Specialist, Quality Assurance

Wilmington, DE · On-site

KBR is looking for a Specialist, Quality Assurance to provide technical expertise in support of the Quality program at the client site in Wilmington, DE. Under general supervision, and occasional ...

KBR

Specialist, Quality Assurance

Wilmington, DE

KBR is looking for aSpecialist, Quality Assurance to provide technical expertise in support of the Quality program at the client site in Wilmington, DE. Under general supervision, and occasional ...

Saransh Inc

QA Automation

Wilmington, DE · On-site

7years to 12 years of experienced and highly skilled QA Automation Tester to join our dynamic team ... in Selenium, JUnit, TestNG, Appium (e) Experience in GIT, JIRA, SQL, BIT BUCKET, Jules (f ...

next page

Showing results 1-20

All JobsQuality Assurance In Pharmaceutical JobsQuality Assurance In Pharmaceutical Jobs in Delaware

Quality Assurance In Pharmaceutical information

What does a quality assurance professional do in the pharmaceutical industry?

A Quality Assurance (QA) professional in the pharmaceutical industry is responsible for ensuring that all products meet established standards of quality, safety, and efficacy. They develop, maintain, and monitor procedures and systems that comply with regulatory requirements such as Good Manufacturing Practices (GMP). QA professionals conduct audits, review documentation, manage deviations, and support continuous improvement to ensure that medications are safe for patients. Their work is critical in preventing errors, ensuring product consistency, and maintaining the trust of regulatory agencies and consumers.

What are the key skills and qualifications needed to thrive as a quality assurance professional in the pharmaceutical industry?

A successful Quality Assurance professional in pharmaceuticals needs a solid background in life sciences or pharmacy, understanding of GMP regulations, and relevant QA experience. Familiarity with quality management systems (QMS), documentation software, and regulatory compliance tools is typically required. Attention to detail, critical thinking, and effective communication are essential soft skills for excelling in this role. These skills ensure product safety, regulatory compliance, and the consistent delivery of high-quality pharmaceutical products.

What are some common challenges faced by quality assurance professionals in the pharmaceutical industry, and how can they be effectively managed?

Quality Assurance (QA) professionals in the pharmaceutical industry often face challenges such as keeping up with evolving regulatory requirements, ensuring consistent documentation, and coordinating cross-functional teams during audits. Managing these challenges requires continuous training, strong attention to detail, and effective communication skills. Collaboration with other departments, such as production and regulatory affairs, is key to identifying issues early and maintaining compliance with Good Manufacturing Practices (GMP). Establishing clear quality procedures and staying proactive with process improvements also help QA professionals maintain high standards and reduce risks.

What is the difference between Quality Assurance In Pharmaceutical vs Quality Control In Pharmaceutical?

AspectQuality Assurance In PharmaceuticalQuality Control In Pharmaceutical
FocusProcesses, compliance, and preventing defectsTesting and inspecting products for defects
ResponsibilitiesDeveloping quality systems, audits, documentationSampling, testing, and analyzing products
CredentialsGMP certifications, quality management trainingLab certifications, analytical testing skills
Work EnvironmentOffice-based, quality departments, manufacturing sitesLaboratories, manufacturing facilities

Quality Assurance In Pharmaceutical focuses on establishing and maintaining quality systems to prevent issues, while Quality Control In Pharmaceutical emphasizes testing products to identify defects. Both roles are essential in ensuring pharmaceutical safety and compliance, but they differ in scope and daily tasks.

Is quality assurance a good career in the pharmaceutical industry?

Quality assurance in the pharmaceutical industry is a stable and growing career, focusing on ensuring products meet safety and regulatory standards. It often requires knowledge of Good Manufacturing Practices (GMP), quality control processes, and relevant certifications. The role offers opportunities for advancement and specialization within the industry.

What does quality assurance do in the pharmaceutical industry?

Quality assurance professionals in the pharmaceutical industry ensure that products meet safety, quality, and regulatory standards throughout the manufacturing process. They develop and implement procedures, conduct audits, and review documentation to prevent defects and ensure compliance with Good Manufacturing Practices (GMP).

What are popular job titles related to Quality Assurance In Pharmaceutical jobs in Delaware?

For Quality Assurance In Pharmaceutical jobs in Delaware, the most frequently searched job titles are:

What job categories do people searching Quality Assurance In Pharmaceutical jobs in Delaware look for?

The top searched job categories for Quality Assurance In Pharmaceutical jobs in Delaware are:

What cities in Delaware are hiring for Quality Assurance In Pharmaceutical jobs?

Cities in Delaware with the most Quality Assurance In Pharmaceutical job openings:

Quality Assurance In Pharmaceutical jobs near you
Infographic showing various Quality Assurance In Pharmaceutical job openings in Delaware as of August 2026, with employment types broken down into 1% As Needed, 79% Full Time, 15% Part Time, 4% Contract, and 1% Nights. Highlights an 87% Physical, 2% Hybrid, and 11% Remote job distribution.

Quality Assurance Specialist - Pharmaceuticals

WuXi AppTec

Middletown, DE • On-site

Other

Re-posted 24 days ago

Job description

Overview
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.

Qualifications
  • 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.

Apply