Quality Assurance Specialist Jobs in Portland, ME
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.
Job Classification: Corporate - Legal and Compliance We are seeking a highly motivated compliance professional to support Prudential's growing Group Insurance disability and absence business. The...
Demographic Data for Portland, ME
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Quality Assurance Specialists in Portland, ME offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Quality Assurance Specialist position
- Verbal Communication
- Environmental Compliance
- Waste Management
- Environmental Management
- Quality Systems
- ISO Certified
- Implementation
- Air Quality
- Inspections
- ISO 13485
- Environmental Education
- Natural Resource Management
- ISO 14001
- Environmental Engineering
- Certified Hazardous Materials Manager
- 21 CFR 820
- Institutional Review Board
- ICH GCP
- Clinical Data Management
- Gene Therapy
- ICH Guidelines
- Good Clinical Practice
- Field Sampling
- Drug Development
- Biology
- Pharmacovigilance
- Good Laboratory Practice
- Clinical Trials
- Biotechnology
- Environmental Science
- Clinical Research
- Genetics
- Medical Device Sales
- FDA Regulations
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- Standard Operating Procedures
- Machine Learning
- Engineering
- Strategy Development
- Risk Management
- 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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