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.
Qualifications Education: A bachelors degree or equivalent experience is required, preferably in Analytical Chemistry, Biochemistry, or Biomedical Engineering....
One of our large pharmaceutical clients in Malvern, PA is seeking a Compliance Specialist to join their growing team supporting the Biologics (large molecule) organization within R&D. This person...
Senior Regulatory Affairs Specialist (Office of Clinical Research)
- Philadelphia, PA
- 30+ days ago
- Philadelphia, PA
- 30+ days ago
This position will support, train and qualify potential IND/IDE/CTA Sponsors of Investigator Initiated Trials throughout the clinical trial life cycle....
NCI/NCTN Regulatory Affairs Specialist Senior (Abramson Cancer Center) (Remote Eligible)
- Philadelphia, PA
- 30+ days ago
- Philadelphia, PA
- 30+ days ago
The ACC is instrumental in the development and implementation of cancer clinical trials that offer cutting-edge oncology treatments. Contingent upon funding....
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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
- English
- Driving
- Environmental Compliance
- Financial Services
- Quality Systems
- ISO Certified
- Geology
- Water Quality
- Implementation
- Air Quality
- Document Control
- Change Control
- Inspections
- ISO 13485
- Quality Management Systems
- Environmental Education
- Natural Resource Management
- Batch Record Review
- GxP
- TrackWise
- 21 CFR 820
- Institutional Review Board
- ICH GCP
- ICH Guidelines
- Lab Safety
- Biology
- Drug Development
- Biochemistry
- Microbiology
- Environmental Monitoring
- Biotechnology
- Clinical Trials
- Clinical Research
- Laboratory Management
- Medical Device Sales
- FDA Regulations
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Military Background
- Auditing
- Investigation
- Written Communication
- Interpersonal Skills
- Quality Assurance
- Collaboration
- Education Experience
- Documentation
- Reporting
- Bachelor's Degree
- Regulations
- Policy Development
- Microsoft Office
- Problem Solving
- Sales
- Research Skills
- Organization
- Scheduling
- Leadership
- Communication Skills
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