Quality Assurance Specialist Jobs in Plymouth, MN
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.
Principal Regulatory Affairs Specialist Vascular (on-site)
- Saint Paul, MN (17 miles from Plymouth, MN)
- 2 days ago
- Saint Paul, MN (17 miles from Plymouth, MN)
- 2 days ago
Chemistry, life Sciences, Biology (or equivalent vocational qualifications) Experienced in regulatory submissions for Pharmaceutical, In vitro diagnostic devices and/or medical devices....
- Minneapolis, MN (7 miles from Plymouth, MN)
- 21 days ago
- Minneapolis, MN (7 miles from Plymouth, MN)
- 21 days ago
This role is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process and sustaining engineering projects, ensuring compliance...
Provides mentoring and leadership to other Regulatory team members Required Qualifications Bachelor's Degree; preferably in a technical discipline such as biology, chemistry, microbiology, immunology...
Senior Regulatory Affairs Specialist
- Maple Grove, MN (8 miles from Plymouth, MN)
- 45+ days ago
- Maple Grove, MN (8 miles from Plymouth, MN)
- 45+ days ago
Additional Location(s): US-MN-Maple Grove Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, well give you the opportunity to harness...
Regulatory Operations Compliance Manager Medical Devices (on-site)
- Maple Grove, MN (8 miles from Plymouth, MN)
- 60+ days ago
- Maple Grove, MN (8 miles from Plymouth, MN)
- 60+ days ago
Preferred Qualifications Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields....
Regulatory Affairs Specialist II Electrophysiology (on-site)
- Plymouth, MN
- 60+ days ago
- Plymouth, MN
- 60+ days ago
Preferred Qualifications Bachelors degree in science (biology, chemistry, microbiology, etc.), math, engineering, or medical fields. Masters degree in Regulatory Affairs....
Demographic Data for Plymouth, MN
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Quality Assurance Specialists in Plymouth, MN offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Quality Assurance Specialist position
- Continuous Improvement
- Filing
- Quality Systems
- ISO Certified
- Implementation
- Groundwater
- Change Control
- Inspections
- ISO 13485
- Quality Management Systems
- Clean Water Act
- Batch Record Review
- GxP
- TrackWise
- 21 CFR 820
- ICH GCP
- Institutional Review Board
- Genomics
- ICH Guidelines
- Gene Therapy
- Lab Safety
- Good Clinical Practice
- Medical Affairs
- Biology
- Ecology
- Microbiology
- Pharmacovigilance
- Environmental Monitoring
- Biotechnology
- Good Laboratory Practice
- Clinical Trials
- Analytical Chemistry
- Clinical Research
- Laboratory Management
- Medical Device Sales
- Good Manufacturing Practices
- FDA Regulations
- Corrective Actions & Preventive Actions
- Standard Operating Procedures
- Diagnostic
- Technical Writing
- Engineering
- Strategy Development
- Risk Management
- Quality Control
- Auditing
- Written Communication
- Documentation
- Investigation
- Collaboration
- Reporting
- Quality Assurance
- Bachelor's Degree
- Microsoft PowerPoint
- Policy Development
- Regulations
- Problem Solving
- Research Skills
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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