Quality Assurance Specialist Jobs in Indiana
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.
Description: The QA Compliance Specialist implements robust Quality Systems for us considering regulatory requirements of the organization. This role contributes significantly to the execution of...
market surveillance and vigilance activities Support Health Hazard Assessments and Field Actions as needed Qualifications Education : Bachelors degree required, preferably in Analytical Chemistry, Biochemistry...
Quality Assurance Associate - Drug Product External Manufacturing
- Indianapolis, IN
- 90+ days ago
- Indianapolis, IN
- 90+ days ago
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world...
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Required or preferred licenses and certifications for Quality Assurance Specialist positions.
Highest Education Level
Quality Assurance Specialists in Indiana offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Quality Assurance Specialist position
- Filing
- Quality Systems
- ISO Certified
- Document Control
- Change Control
- Inspections
- ISO 13485
- Quality Management Systems
- GxP
- TrackWise
- 21 CFR 820
- ICH GCP
- Institutional Review Board
- Gene Therapy
- Lab Safety
- Good Clinical Practice
- ICH Guidelines
- Medical Affairs
- Biology
- Drug Development
- Microbiology
- Pharmacovigilance
- Environmental Monitoring
- Biomedical Engineering
- Good Laboratory Practice
- Analytical Chemistry
- Clinical Trials
- Biotechnology
- Toxicology
- Clinical Research
- Environmental Science
- Medical Device Sales
- Good Manufacturing Practices
- FDA Regulations
- Corrective Actions & Preventive Actions
- Standard Operating Procedures
- Product Development
- Technical Writing
- Engineering
- Strategy Development
- Quality Control
- Auditing
- Written Communication
- Documentation
- Education Experience
- Investigation
- Collaboration
- Reporting
- Quality Assurance
- Interpersonal Skills
- Bachelor's Degree
- Microsoft PowerPoint
- Policy Development
- Problem Solving
- Regulations
- Research Skills
- Microsoft Office
- Microsoft Excel
- Microsoft Word
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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