Quality Assurance Specialist Jobs in Michigan
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.
Quality, Service, Collaboration, Courage. Do you exhibit these values and wish to be around others that do too? Are you interested in making a difference in your community and the world? Are you...
Position Details Position Purpose The regulatory compliance specialist works under the direction of the IRB Manager at Oakland University to provide ongoing support to the Institutional Review Board...
Regulatory Compliance Specialist Oakland University
- Rochester, MI
- 25 days ago
- Rochester, MI
- 25 days ago
Position Purpose: The regulatory compliance specialist works under the direction of the IRB Manager at Oakland University to provide ongoing support to the Institutional Review Board (IRB) for the protection...
Job Description: Company: Tata Elxsi Limited Position Title: Regulatory Affairs Specialist Location: 2701 Troy Center Drive, Troy, MI 48084 and unanticipated client locations throughout the U.S....
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Highest Education Level
Quality Assurance Specialists in Michigan 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
- Filing
- Environmental Compliance
- NEPA
- CERCLA
- Environmental Management
- Quality Systems
- ISO Certified
- Implementation
- Air Quality
- Inspections
- ISO 13485
- Clean Water Act
- Environmental Education
- Clean Air Act
- Natural Resource Management
- ISO 14001
- Certified Hazardous Materials Manager
- Internal Audits
- GxP
- 21 CFR 820
- Institutional Review Board
- ICH GCP
- Clinical Data Management
- Good Clinical Practice
- Gene Therapy
- ICH Guidelines
- Field Sampling
- Biology
- Ecology
- Pharmacovigilance
- Good Laboratory Practice
- Biotechnology
- Clinical Trials
- Clinical Research
- Environmental Science
- Genetics
- FDA Regulations
- Medical Device Sales
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- Standard Operating Procedures
- Engineering
- Affirmative Action
- Strategy Development
- Quality Control
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Reporting
- Education Experience
- Bachelor's Degree
- Microsoft PowerPoint
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Leadership
- Communication Skills
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