Quality Assurance Specialist Jobs in Pennsylvania
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 (Submissions) Regulatory Affairs Remote, PA, US Pay Rate Low: 70.00 | Pay Rate High: 75.00 Our client, a global biopharmaceutical company dedicated to transforming...
Remote WorkLegal Operations & Contract Compliance Specialist
- Harrisburg, PA
- 12 days ago
- Harrisburg, PA
- 12 days ago
Who we are:** Rubrik is one of the fastest growing companies in Silicon Valley, revolutionizing data protection and management in the emerging multi-cloud IT industry. Recently a Top 10 of the...
Remote WorkDemonstrates comprehension and understanding of federal regulations and guidelines of the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Good Clinical Practice Guidelines...
An employer in the Life Sciences industry is looking for a Global Trade Compliance Analyst. This role will be performing data cleansing and classification for a high volume of backlogged product...
West Pharmaceutical Services, Inc. seeks a Senior Regulatory Affairs Specialist at its Exton, PA location. DUTIES: Develop and implement regulatory strategies for West's Administration System...
Remote WorkQuality Control Compliance Specialist, CAPAs & Change Controls
- Philadelphia, PA
- 30+ days ago
- Philadelphia, PA
- 30+ days ago
Overview Iovance Biotherapeutics is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies. Iovance is seeking a Quality Control (QC)...
Regulatory Affairs Specialist Senior (Department of Ophthalmology)
- Philadelphia, PA
- 45+ days ago
- Philadelphia, PA
- 45+ 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...
Senior Vice President, Consumer Compliance Officer Treasury Services
- Pittsburgh, PA
- 60+ days ago
- Pittsburgh, PA
- 60+ days ago
Senior Vice President, Consumer Compliance Officer Treasury Services. At BNY, our culture empowers you to grow and succeed. As a leading global financial services company at the center of the...
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Quality Assurance Specialists in Pennsylvania offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Quality Assurance Specialist position
- Environmental Compliance
- Quality Systems
- Geology
- Water Quality
- Implementation
- Air Quality
- Inspections
- ISO 13485
- Environmental Education
- Natural Resource Management
- Batch Record Review
- GxP
- ASQ Certified Quality Auditor
- 21 CFR 820
- Institutional Review Board
- ICH GCP
- Clinical Data Management
- Gene Therapy
- ICH Guidelines
- Good Clinical Practice
- Mammalian Cell Culture
- Field Sampling
- Environmental Monitoring
- Biology
- Biochemistry
- Pharmacovigilance
- Microbiology
- Clinical Trials
- Biotechnology
- Good Laboratory Practice
- Clinical Research
- Genetics
- Medical Device Sales
- FDA Regulations
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- Standard Operating Procedures
- Machine Learning
- Engineering
- Strategy Development
- Process Improvement
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Interpersonal Skills
- Bachelor's Degree
- Reporting
- Education Experience
- Regulations
- Sales
- Policy Development
- Project Management
- Problem Solving
- Research Skills
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Customer Service
- Scheduling
- Leadership
- Communication Skills
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