Quality Assurance Specialist Jobs in Indianapolis, IN
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.
Senior QA Compliance Auditor (Science Industry)
- Indianapolis, IN
- 3 days ago
- Indianapolis, IN
- 3 days ago
Qualifications: Must have an industry-related Bachelor's degree (Chemistry, Biochemistry, Biology, Medical Laboratory Science, Pharmaceutical Sciences, etc.)...
Compliance Analyst III Job Description Job Title: Compliance Analyst III/ Senior QA Compliance Auditor Duration: 6 Months (CONTRACT TO HIRE POSSIBILITY) Shift Time: 8:00 AM to 5:00 PM Mon-Fri (1st...
Quality & Regulatory Compliance Analyst (Hybrid)
- Indianapolis, IN
- 6 days ago
- Indianapolis, IN
- 6 days ago
If you are wondering what makes TRIMEDX different, it's that all of our associates share in a common purpose of serving clients, patients, communities, and each other with equal measures of care...
- Greenfield, IN (17 miles from Indianapolis, IN)
- 7 days ago
- Greenfield, IN (17 miles from Indianapolis, IN)
- 7 days ago
Good Clinical Practice (GCP), and Good Laboratory Practice (GLP) in the performance of their role....
A minimum of a Bachelor's Degree in a Pharmacy, Chemistry, or Biology-related discipline. Postgraduate degree (MSC or equivalent) in science or management-related discipline preferred....
Quality Assurance Associate - Drug Product External Manufacturing
- Indianapolis, IN
- 9 days ago
- Indianapolis, IN
- 9 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...
Compliance Analyst (Medical Device Industry)
- Indianapolis, IN
- 9 days ago
- Indianapolis, IN
- 9 days ago
influence QA strategy systems/standards and ability to apply appropriate regulatory knowledge to multiple scenarios Preferred Qualifications: A minimum of a Bachelor's Degree in a Pharmacy, Chemistry or Biology...
standards and ability to apply appropriate regulatory knowledge to multiple scenarios Education/Qualifications/Certifications and Licenses A minimum of a Bachelor’s Degree in a Pharmacy, Chemistry or Biology...
Finance Risk Compliance - Consultant/Manager
- Carmel, IN (14 miles from Indianapolis, IN)
- 12 days ago
- Carmel, IN (14 miles from Indianapolis, IN)
- 12 days ago
Job Description In Strategy & Consulting we work with C-suite executives, leaders and boards of the world's leading organizations, helping them reinvent every part of their enterprise to drive...
BA or BS, or higher, in Chemistry, Biochemistry, Biological Science, or related discipline required. ? One year of relevant laboratory experience required. ?...
Job Description Summary At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted...
Demographic Data for Indianapolis, IN
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Salary for Quality Assurance Specialist Jobs in Indianapolis, IN
Required or preferred licenses and certifications for Quality Assurance Specialist positions.
Highest Education Level
Quality Assurance Specialists in Indianapolis, IN offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Quality Assurance Specialist position
- Consulting
- Decision Making
- Environmental Compliance
- Environmental Management
- Quality Systems
- ISO Certified
- Treasury
- Implementation
- Securities and Exchange Commission
- Balance Sheets
- Treasury Management
- Inspections
- ISO 13485
- Quality Management Systems
- Environmental Education
- Capital Markets
- Anti-Money Laundering
- Management Consulting
- ISO 14001
- Certified Hazardous Materials Manager
- HACCP Certified
- GxP
- Supplier Auditing
- Comprehensive Capital Analysis and Review
- 21 CFR 820
- Institutional Review Board
- ICH Guidelines
- Environmental Monitoring
- Biology
- Clinical Trials
- Biotechnology
- Environmental Science
- Genetics
- FDA Regulations
- Medical Device Sales
- Good Manufacturing Practices
- Corrective Actions & Preventive Actions
- Standard Operating Procedures
- Engineering
- Affirmative Action
- Strategy Development
- Risk Management
- Investigation
- Auditing
- Written Communication
- Documentation
- Quality Assurance
- Collaboration
- Bachelor's Degree
- Reporting
- Education Experience
- Microsoft PowerPoint
- Regulations
- Policy Development
- Project Management
- Research Skills
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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