Manager of Quality Assurance and Regulatory Affairs Jobs in Tennessee
A Manager of Quality Assurance and Regulatory Affairs in the biotechnology industry is responsible for ensuring that all products and services meet required standards and regulations. They ensure compliance with local, national, and international regulatory requirements, oversee quality control processes, and manage audits and inspections. This role also involves creating and implementing policies and procedures to enhance product quality, efficiency, and safety. They also play a crucial role in the product development process, advising on regulatory requirements and ensuring that compliance is maintained throughout the lifecycle of a product.
Skills required for this role include excellent attention to detail, strong organizational and leadership skills, and in-depth knowledge of regulatory standards and quality control methods. In addition, they should have excellent problem-solving skills, the ability to work under pressure, and strong communication skills. They should also have a strong understanding of biotechnology principles and processes. Certifications such as Certified Quality Auditor (CQA), Certified Quality Manager (CQM), or Regulatory Affairs Certification (RAC) are often required. Prior roles that can lead to a Manager of Quality Assurance and Regulatory Affairs include Quality Assurance Specialist, Regulatory Affairs Associate, and Quality Control Supervisor.
walking manufacturing floor, climbing stairs, and lift up to 25lbs Minimum Qualifications Associates degree or up to 3 years of college or technical school (preferred area of study: Food Science, Biology...
The Quality Assurance Director will provide compliance leadership and direction to our Company and contract manufacturing operation (CMO) sites that manufacture active pharmaceutical ingredients...
Overview of the role This role provides timely and accurate analytical support to production, leadership and manages laboratory personnel in support of site operations with the objective of...
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...
Labcorp is seeking a Clinical Laboratory Manager to join our team at University of Tennessee Medical Center in Knoxville, TN. This position will be responsible for overseeing the operations and...
This person will also assist with coordination of organizational aspects, execution of clinical trials, technical measures and duties as assigned to serve the needs of Faculty & students participating...
Anatomy Lab Manager, DCOM - Orange Park Department: DCOM BASIC SCIENCES Position Category: Staff Full Time Job Description: The Anatomy Lab Facilities Manager for the Lincoln Memorial University...
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Highest Education Level
Manager of Quality Assurance and Regulatory Affairss in Tennessee offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Manager of Quality Assurance and Regulatory Affairs position
- Mentoring
- Quality Systems
- Implementation
- Quality Management
- Coaching
- Inspections
- Quality Management Systems
- Batch Record Review
- GxP
- TrackWise
- ICH GCP
- Institutional Review Board
- Animal Models
- Spectrophotometer
- Gene Therapy
- Proteomics
- ICH Guidelines
- Lab Safety
- Neurobiology
- Molecular Biology
- Clinical Laboratory Operations
- Scientific Research
- Biology
- Biochemistry
- Drug Development
- Immunology
- Microbiology
- Immunohistochemistry
- Medical Writing
- Experimental Design
- Biotechnology
- Good Laboratory Practice
- Clinical Trials
- Laboratory Management
- Equipment Calibration
- Medical Device Sales
- Good Manufacturing Practices
- FDA Regulations
- Research and Development
- Standard Operating Procedures
- General Repair
- Masters In Education
- Engineering
- Strategy Development
- Quality Control
- Auditing
- Investigation
- Written Communication
- Education Experience
- Documentation
- Quality Assurance
- Collaboration
- Interpersonal Skills
- Reporting
- Policy Development
- Bachelor's Degree
- Inventory Management
- Regulations
- Project Management
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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