Quality Assurance Specialist Jobs in Wilmington, DE
A Quality Assurance (QA) Specialist in the biotechnology industry is responsible for ensuring that the biomedical products, pharmaceuticals, and medical devices produced meet strict quality standards. They conduct routine audits, develop quality control procedures, and oversee the manufacturing process to ensure compliance with legal regulations and industry standards. QA Specialists also assist in problem-solving efforts relating to quality management and perform regular inspections, documenting any discrepancies and implementing corrective actions when necessary.
A strong candidate for a QA Specialist typically requires a bachelor's degree in biology, chemistry, or a related field. They should have excellent attention to detail, strong communication skills, and the ability to work in a regulated environment. A working knowledge of FDA regulations, ISO standards, and GMP (Good Manufacturing Practices) is often required. Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Certified Quality Improvement Associate (CQIA) are relevant certifications. Prior to becoming a QA Specialist, a person might have roles such as a Lab Technician, Quality Control Analyst, or Research Associate in the biotechnology field.
Regulatory Affairs Specialist Senior (Department of Ophthalmology) University of Pennsylvania
- Philadelphia, PA (24 miles from Wilmington, DE)
- 12 hours ago
- Philadelphia, PA (24 miles from Wilmington, DE)
- 12 hours ago
The regulatory aspects of the initiation of Phase I-V clinical trials with a focus on required regulatory start-up approvals and associated site initiation documentation....
Regulatory Affairs Specialist Senior (Department of Ophthalmology)
- Philadelphia, PA (24 miles from Wilmington, DE)
- 18 hours ago
- Philadelphia, PA (24 miles from Wilmington, DE)
- 18 hours ago
The regulatory aspects of the initiation of Phase I-V clinical trials with a focus on required regulatory start-up approvals and associated site initiation documentation....
Quality Assurance Associate III
- Malvern, PA (22 miles from Wilmington, DE)
- 1 day ago
- Malvern, PA (22 miles from Wilmington, DE)
- 1 day ago
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments...
NCI/NCTN Regulatory Affairs Specialist Senior (Abramson Cancer Center) (Remote Eligible)
- Philadelphia, PA (24 miles from Wilmington, DE)
- 9 days ago
- Philadelphia, PA (24 miles from Wilmington, DE)
- 9 days ago
GCP guidelines....
Remote WorkSenior Regulatory Affairs Specialist (Office of Clinical Research)
- Philadelphia, PA (24 miles from Wilmington, DE)
- 9 days ago
- Philadelphia, PA (24 miles from Wilmington, DE)
- 9 days ago
This position will support, train and qualify potential IND/IDE/CTA Sponsors of Investigator Initiated Trials throughout the clinical trial life cycle....
- Philadelphia, PA (24 miles from Wilmington, DE)
- 9 days ago
- Philadelphia, PA (24 miles from Wilmington, DE)
- 9 days ago
The ACC Clinical Research Unit (CRU) is instrumental in the development and implementation of cancer clinical trials that offer cutting-edge oncology treatments....
Finance Risk Compliance - Consultant/Manager
- Philadelphia, PA (24 miles from Wilmington, DE)
- 12 days ago
- Philadelphia, PA (24 miles from Wilmington, DE)
- 12 days ago
Job Description In Strategy & Consulting we work with C-suite executives, leaders and boards of the world's leading organizations, helping them reinvent every part of their enterprise to drive...
Net2Source is a Global Workforce Solutions Company headquartered at NJ, USA with its branch offices in Asia Pacific Region. We are one of the fastest growing IT Consulting company across the USA...
Net2Source is a Global Workforce Solutions Company headquartered at NJ, USA with its branch offices in Asia Pacific Region. We are one of the fastest growing IT Consulting company across the USA...
Quality Assurance Compliance Specialist
- Philadelphia, PA (24 miles from Wilmington, DE)
- 90+ days ago
- Philadelphia, PA (24 miles from Wilmington, DE)
- 90+ days ago
Overview Primary Quality Assurance Representative for review of GLP Final Reports, GMP Certificates of Analysis (CoAs), Assay Validations, deviations, and CAPAs. Reviews laboratory testing data or...
- Malvern, PA (22 miles from Wilmington, DE)
- 90+ days ago
- Malvern, PA (22 miles from Wilmington, DE)
- 90+ days ago
Title: Quality Assurance Associate Job Purpose: To mainly provide support to the CAPA System, Trainings and Vendor qualification process and records review. Main Duties and Responsibilities:...
Regulatory Affairs Specialist C
- Philadelphia, PA (24 miles from Wilmington, DE)
- 90+ days ago
- Philadelphia, PA (24 miles from Wilmington, DE)
- 90+ days ago
University Overview The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League...
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Salary for Quality Assurance Specialist Jobs in Wilmington, DE
Required or preferred licenses and certifications for Quality Assurance Specialist positions.
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Quality Assurance Specialists in Wilmington, DE offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Quality Assurance Specialist position
- Consulting
- Decision Making
- Environmental Compliance
- Environmental Management
- Quality Systems
- ISO Certified
- Treasury
- Implementation
- Securities and Exchange Commission
- Balance Sheets
- Treasury Management
- Inspections
- ISO 13485
- Quality Management Systems
- Environmental Education
- Capital Markets
- Anti-Money Laundering
- Management Consulting
- ISO 14001
- Certified Hazardous Materials Manager
- HACCP Certified
- GxP
- GFSI
- Supplier Auditing
- Comprehensive Capital Analysis and Review
- 21 CFR 820
- Institutional Review Board
- ICH Guidelines
- Environmental Monitoring
- Biology
- Biotechnology
- Environmental Science
- Genetics
- FDA Regulations
- Medical Device Sales
- Good Manufacturing Practices
- Corrective Actions & Preventive Actions
- Standard Operating Procedures
- Engineering
- Affirmative Action
- Strategy Development
- Risk Management
- Investigation
- Auditing
- Written Communication
- Documentation
- Quality Assurance
- Collaboration
- Bachelor's Degree
- Reporting
- Education Experience
- Microsoft PowerPoint
- Regulations
- Policy Development
- Project Management
- Research Skills
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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