Manager of Quality Assurance and Regulatory Affairs Jobs in Michigan
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.
Dairy Distillery Alliance, a biofuels manufacturer in Constantine, MI is a new organization that is using milk permeate from the MMPA (Michigan Milk Producers Association), a byproduct of the...
The Mental Health Services, Innovation, and Outcomes (MHISO) program in the Department of Psychiatry conducts cutting-edge mental health services research to address critical challenges such as...
MHISO Lab Manager (1 YR Term Limited) University of Michigan - Ann Arbor
- Ann Arbor, MI
- 4 days ago
- Ann Arbor, MI
- 4 days ago
The Mental Health Services, Innovation, and Outcomes (MHISO) program in the Department of Psychiatry conducts cutting-edge mental health services research to address critical challenges such as...
Linguistics Lab Manager University of Michigan - Ann Arbor
- Ann Arbor, MI
- 5 days ago
- Ann Arbor, MI
- 5 days ago
A cover letter is required for consideration for this position and should be attached as the first page of your CV. The cover letter should address your specific interest in the position and...
How to Apply A cover letter is required for consideration for this position and should be attached as the first page of your CV. The cover letter should address your specific interest in the...
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Required or preferred licenses and certifications for Manager of Quality Assurance and Regulatory Affairs positions.
Highest Education Level
Manager of Quality Assurance and Regulatory Affairss in Michigan 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
- Change Control
- Quality Management Systems
- Batch Record Review
- Internal Audits
- GxP
- TrackWise
- Institutional Review Board
- Assay Development
- Biomarkers
- CRISPR
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Genotyping
- Next-Generation Sequencing
- Cell Culture
- Mammalian Cell Culture
- Molecular Biology
- Cloning
- Clinical Laboratory Operations
- Confocal Microscopy
- Polymerase Chain Reaction
- Drug Development
- Western Blot
- Biology
- Pharmacovigilance
- Stem Cells
- Microbiology
- Enzyme-Linked ImmunoSorbent Assay
- Clinical Trials
- Good Laboratory Practice
- Biotechnology
- Clinical Research
- Laboratory Management
- FDA Regulations
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Strategy Development
- Engineering
- Quality Control
- Investigation
- Auditing
- Written Communication
- Documentation
- Quality Assurance
- Collaboration
- Interpersonal Skills
- Bachelor's Degree
- Education Experience
- Inventory Management
- Reporting
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Teamwork
- Research Skills
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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