Director of Quality Assurance and Regulatory Affairs Jobs in Florida
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.
Your Education & Experience: Bachelor’s Degree in Food Science, Biology, Microbiology, Chemistry, or related field. 5+ years in food manufacturing required, with 3+ years in the Technical and Quality...
Preferred Certifications ASCP Certification in Molecular Biology (MB) or Clinical Laboratory Director eligibility....
Position Highlights: Work in a dynamic environment with opportunities to collaborate with biomedical data scientists, software engineers, cancer biology researchers, and physicians....
standard lab and plant operating procedures Foster a culture of compliance, professionalism, and continuous development across the lab team Minimum Specifications Education: Bachelor of Science in Biology...
oin Our Team at Tallahassee State College Nursing Lab Manager Opportunity Tallahassee State College is excited to announce a full-time opening for the position of Nursing Lab Manager - P01144 in...
Master basic biological/biochemistry experiment skills including but limited to cell culture, RT-qPCR, WB, IF....
California, US residents click here (. **The job details are as follows:** **Who we are** We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit...
We are the movers of the world and the makers of the future. We get up every day, roll up our sleeves and build a better world -- together. At Ford, we're all a part of something bigger than...
- New Port Richey, FL
- 16 days ago
- New Port Richey, FL
- 16 days ago
Company Description ProSidian is a Management and Operations Consulting Services Firm focusing on providing value to clients through tailored solutions based on industry-leading practices....
Associate Director, Regulatory Affairs - Plasma Services
- Boca Raton, FL
- 29 days ago
- Boca Raton, FL
- 29 days ago
Job Details Job Location: ADMA Biologics FL - Boca Raton, FL Salary Range: Undisclosed Description ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior...
Location: REMOTE Salary: $190,000.00 USD Annually - $215,000.00 USD Annually Description: Our client is currently seeking a Director, Regulatory Affairs Strategy who will be responsible for...
development and process improvement projects Strong background in Next-Generation Sequencing (NGS) and molecular diagnostics....
This position has a $10,000 sign on bonus. (External candidates only.) Labcorp is seeking a Clinical Laboratory Manager to join our team at Ascension St Vincent's Riverside, Jacksonville, Florida....
WHO WE ARE & WHAT WE DO Tallahassee Memorial Healthcare (TMH) is a private, nonprofit community-based healthcare system that provides care to a 22-county region in North Florida and South Georgia....
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Director of Quality Assurance and Regulatory Affairss in Florida 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
- Mentoring
- Electrical Engineering
- Employee Development
- Affirmative Action
- Quality Systems
- ISO Certified
- Implementation
- Hazardous Materials
- Quality Management
- Document Control
- Coaching
- Inspections
- ISO 13485
- Quality Management Systems
- Control Systems
- Batch Record Review
- GxP
- TrackWise
- Institutional Review Board
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Molecular Biology
- Genotyping
- Drug Development
- Biology
- Biochemistry
- Microbiology
- Biotechnology
- Good Laboratory Practice
- Laboratory Management
- Medical Device Sales
- Equipment Calibration
- Good Manufacturing Practices
- FDA Regulations
- Corrective Actions & Preventive Actions
- Research and Development
- Process Development
- Masters In Education
- Engineering
- Strategy Development
- Auditing
- Investigation
- Written Communication
- Quality Assurance
- Collaboration
- Documentation
- Regulations
- Inventory Management
- Project Management
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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