Director of Quality Assurance and Regulatory Affairs Jobs in Indiana
A Director of Quality Assurance and Regulatory Affairs in the biotechnology industry is essentially responsible for developing and implementing systems that ensure products meet quality standards and regulatory requirements. This includes conducting internal audits, leading investigations into quality issues, liaising with regulatory bodies, and overseeing the submission of regulatory documents. They are also responsible for ensuring compliance with regulatory requirements and standards such as ISO, FDA, and EMEA. They play a crucial role in maintaining the company's reputation and ensuring customer satisfaction by ensuring that products are safe, reliable, and meet both customer and regulatory requirements.
Key skills for this role include strong analytical and problem-solving skills, excellent communication skills, and a strong knowledge of the biotechnology industry and its associated regulations. They should also have strong leadership skills, as they will often be leading teams and coordinating with other departments. Important certifications may include Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Regulatory Affairs Certification (RAC), or Certified Quality Manager (CQM). Prior to becoming a Director of Quality Assurance and Regulatory Affairs, an individual may have roles such as Quality Assurance Manager, Regulatory Affairs Specialist, or Senior Quality Engineer within the industry.
The Quality Assurance Manager, is responsible for the management of a Quality Assurance Program at their Inotiv site that encompasses the relevant aspects of appropriate federal regulations. The...
Duties and Requirements Click to read more Duties Job Duties Administer the Regional Laboratorys evidence system. Participate in the establishment of Regional Laboratory priorities, goals, and...
Forensic Scientist EVII-Lab Manager - Evansville Regional Laboratory
- Evansville, IN
- 8 days ago
- Evansville, IN
- 8 days ago
***STARTING SALARY MAY BE ADJUSTED FOR EDUCATION, EXPERIENCE AND TRAINING*** ***FOR CURRENT STATE EMPLOYEES, ESTABLISHED SALARY RULES APPLY*** To serve as a civilian employee of the Indiana State...
Director, Quality Assurance (Chicago Metropolitan Area)
- Portage, IN
- 16 days ago
- Portage, IN
- 16 days ago
Advanced degree in chemistry, engineering, biochemistry, or related science field desirable....
Gpac has an exciting opportunity for a Quality Director position in KY. The company produces sliced meat for one of the largest big-box stores in America. This plant operates 24/7 across three...
Job Description Overview Indiana University Health is unlike any other healthcare system and we're looking for team members who share the things that matter most to us. People who are inspired by...
Gpac has an exciting opportunity for a Quality Director position in KY. The company produces sliced meat for one of the largest big-box stores in America. This plant operates 24/7 across three...
Partner Job Genezen Director of Quality Assurance QA QA Test Automation Indiana, United States Show interest About The field of gene therapy is growing rapidly and Genezen is here to meet the...
Labcorp is seeking a Clinical Laboratory Manager to join our team in Greenwood, IN. The Laboratory Manager will create, implement, and manage the policies, procedures and practices for optimal...
biology techniques Experience in DNA and RNA extraction methodologies Demonstrated initiative and the ability to organize multiple activities on a daily basis Ability to analyze and make good judgment...
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Director of Quality Assurance and Regulatory Affairss in Indiana offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Director of Quality Assurance and Regulatory Affairs position
- Quality Systems
- Supplier Management
- Implementation
- Interpersonal Skills
- Inspections
- Quality Management Systems
- Batch Record Review
- GxP
- Food Manufacturing
- 21 CFR 820
- Institutional Review Board
- Cell Biology
- Assay Development
- Transfection
- Real-Time Polymerase Chain Reaction
- Gene Therapy
- ICH Guidelines
- Genotyping
- Good Clinical Practice
- Lab Safety
- Molecular Biology
- Tissue Culture
- Polymerase Chain Reaction
- Pharmacovigilance
- Clinical Laboratory Operations
- Cell Culture
- DNA Isolation
- Drug Development
- Medical Writing
- Biochemistry
- Microbiology
- Biology
- Immunology
- DNA/RNA Extraction
- Microscopy
- Good Laboratory Practice
- Biotechnology
- Laboratory Management
- Validation
- FDA Regulations
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Quality Control
- Investigation
- Auditing
- Written Communication
- Documentation
- Quality Assurance
- Collaboration
- Bachelor's Degree
- Reporting
- Education Experience
- Inventory Management
- Regulations
- Policy Development
- Project Management
- Research Skills
- Microsoft Office
- Problem Solving
- Teamwork
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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