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.
Preferred Qualifications Bachelors degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred....
Regulatory Affairs Specialist II Electrophysiology (on-site)
- Plymouth, MN
- 30+ days ago
- Plymouth, MN
- 30+ days ago
Preferred Qualifications Bachelors degree in science (biology, chemistry, microbiology, etc.), math, engineering, or medical fields. Masters degree in Regulatory Affairs....
Principal Regulatory Affairs Specialist US New Product Introduction Diabetes Care (on-site)
- Alameda, CA
- 60+ days ago
- Alameda, CA
- 60+ days ago
Chemistry, life Sciences, Biology (or equivalent vocational qualifications) Experienced in regulatory submissions for Pharmaceuticals, medical devices, and/or in vitro diagnostic devices....
Hershey, PA 3 DAYS AGO 21598809 Summary Hershey, PA Competitive Salary 1 Years Experience Bachelor's degree No Commisssion 40.00 hours per week / Day Shift /Full-Time Description Reference #:...
Sr. Regulatory Affairs Specialist (Global Labeling Lead)
- Alachua, FL
- 3 days ago
- Alachua, FL
- 3 days ago
Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a...
ABOUT GLENMARK: Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules both New Chemical Entities (NCEs) and New...
Research Compliance Coordinator Radford University in Radford, VA Apply Now Type: Full-Time Salary: Salary: Commensurate with experience Posted: 07/07/2025 Category: Assessment, Accreditation, and...
Sr Product Stewardship & Regulatory Affairs Specialist Job
- Radnor, PA
- 4 days ago
- Radnor, PA
- 4 days ago
Degree in relevant field of study (e.g. environmental science, biology, chemical engineering, chemistry, toxicology) or equivalent Minimum of 5 years' experience in product stewardship/regulatory affairs...
trials and to the market....
Description: The QA Compliance Specialist implements robust Quality Systems for us considering regulatory requirements of the organization. This role contributes significantly to the execution of...
Nova Biomedical is hiring a Regulatory Affairs Specialist II to join our team in Waltham, MA. Regulatory Affairs Specialist II is a growth opportunity for individuals with some experience, who are...
trials and to the market....
Job Title: Technical Writer Compliance Job Description We are seeking a skilled Technical Writer Compliance professional who will be responsible for writing and completing investigations and...
Familiarity with Good Clinical Practice (GCP) guidelines. Coding or revenue cycle experience. Professional certification applicable to compliance or clinical research (i.e....
Minimum Education Associate's Degree Biology or a related discipline. (Required) Bachelor's Degree Biology or a related discipline....
Quality Assurance Specialist Online Courses and Training Opportunities
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Required or preferred licenses and certifications for Quality Assurance Specialist positions.
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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
- English
- Accounting
- Driving
- Financial Services
- Quality Systems
- ISO Certified
- Implementation
- Change Control
- ISO 13485
- Quality Management Systems
- Internal Audits
- GxP
- TrackWise
- 21 CFR 820
- Institutional Review Board
- ICH GCP
- Good Clinical Practice
- ICH Guidelines
- Lab Safety
- Medical Affairs
- Cell Culture
- Scientific Research
- Biology
- Biochemistry
- Microbiology
- Environmental Monitoring
- Biomedical Engineering
- Stem Cells
- Biotechnology
- Clinical Trials
- Clinical Research
- Animal Care
- Medical Device Sales
- Corrective Actions & Preventive Actions
- FDA Regulations
- Good Manufacturing Practices
- Process Development
- Standard Operating Procedures
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Auditing
- Investigation
- Written Communication
- Education Experience
- Interpersonal Skills
- Quality Assurance
- Collaboration
- Documentation
- Reporting
- Bachelor's Degree
- Regulations
- Policy Development
- Microsoft Office
- Problem Solving
- Research Skills
- Microsoft Excel
- Organization
- Scheduling
- Leadership
- Communication Skills
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