Quality Assurance Specialist Jobs
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.
Regulatory Affairs Specialist I - Heart Failure (on-site)
- Pleasanton, CA
- 2 days ago
- Pleasanton, CA
- 2 days ago
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses...
Principal Regulatory Affairs Specialist - Vascular (on-site)
- Saint Paul, MN
- 8 days ago
- Saint Paul, MN
- 8 days ago
Chemistry, life Sciences, Biology (or equivalent vocational qualifications) Experienced in regulatory submissions for Pharmaceutical, In vitro diagnostic devices and/or medical devices....
Stroke Compliance Coordinator Registered Nurse RN
- Mechanicsville, VA
- 20 days ago
- Mechanicsville, VA
- 20 days ago
Description Introduction Are you looking for a place to deliver excellent care patients deserve? At Johnston-Willis Hospital we support our colleagues in their positions. Join our Team as a(an)...
DEPT OF HEALTH SERVICES The Arizona Department of Health Services promotes and protects the health of Arizona's children and adults. Our mission is to promote, protect, and improve the health and...
Regulatory Affairs Specialist Senior (Department of Ophthalmology) University of Pennsylvania
- Philadelphia, PA
- 6 hours ago
- Philadelphia, PA
- 6 hours ago
The regulatory aspects of the initiation of Phase I-V clinical trials with a focus on required regulatory start-up approvals and associated site initiation documentation....
Regulatory Affairs Specialist Senior (Department of Ophthalmology)
- Philadelphia, PA
- 12 hours ago
- Philadelphia, PA
- 12 hours ago
The regulatory aspects of the initiation of Phase I-V clinical trials with a focus on required regulatory start-up approvals and associated site initiation documentation....
Regulatory Affairs Specialist Job Description We are seeking a Regulatory Affairs Contractor to contribute to the development and execution of effective regulatory strategies for investigational...
Job Description Reviews and prepares clinical trial documentation for submission of new clinical trials, annual reviews, amendments, addendums, and updates to the Institutional Review Board (IRB)....
Regulatory Compliance Coordinator - Melanoma Medical Oncology
- Houston, TX
- 16 hours ago
- Houston, TX
- 16 hours ago
Assist the Director of Clinical Research, Faculty, and Management team to develop, implement, and execute new clinical trial research processes....
., Clinical Research Coordinator), human subject protection, institutional review board, research ethics, research compliance and/or a related field....
Reference #: REQ_...APPLICATION INSTRUCTIONS:CURRENT PENN STATE EMPLOYEE (faculty, staff, technical service, or student), please login to Workday to complete the internal application process....
At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new...
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments...
Qualifications: Bachelor’s degree with preference for engineering or science background including environmental science, chemistry, geology, or biology....
ADVANCE YOUR CAREER WHILE SAVING LIVES Location: Oklahoma City, OK Pay: Competitive pay based on education and/or experience and $500 bonus after 6 months and $1,000 bonus after 1 year! Benefits:...
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Required or preferred licenses and certifications for Quality Assurance Specialist positions.
Highest Education Level
Quality Assurance Specialists 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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