Quality Assurance Specialist Jobs in Waltham, MA
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.
Compliance Specialist - Conflicts of Interest, Life Sciences
- Boston, MA (10 miles from Waltham, MA)
- 3 days ago
- Boston, MA (10 miles from Waltham, MA)
- 3 days ago
You are someone who thrives in a high-performance environment, bringing a growth mindset and entrepreneurial spirit to tackle meaningful challenges that have a real impact. In return for your...
- Cambridge, MA (6 miles from Waltham, MA)
- 12 days ago
- Cambridge, MA (6 miles from Waltham, MA)
- 12 days ago
USA - Compliance Analyst#25-67892 Cambridge, MA All On-site Job Description Actual Job title: Associate Director, PSPV Compliance & Analytics Objective / Purpose: The Associate director, PSPV...
Remote Work- Boston, MA (10 miles from Waltham, MA)
- 12 days ago
- Boston, MA (10 miles from Waltham, MA)
- 12 days ago
About the Job The Director, Compliance Officer is a member of the Legal and Compliance Department and is responsible for partnering with the business to implement the Business Ethics and...
IT Infrastructure & Compliance Specialist
- Boston, MA (10 miles from Waltham, MA)
- 18 days ago
- Boston, MA (10 miles from Waltham, MA)
- 18 days ago
We are seeking an experienced IT Infrastructure & Compliance Specialist to support enterprise-scale vulnerability remediation, OS upgrade projects, and infrastructure compliance across lab and...
USA-Quality Assurance Associate II (Scientific)
- Cambridge, MA (6 miles from Waltham, MA)
- 22 days ago
- Cambridge, MA (6 miles from Waltham, MA)
- 22 days ago
Coordinate with dossier management group and biology leads to ensure study report conforms with the prescribed formatting requirements. 3....
Senior U.S. Compliance Manager
- Boston, MA (10 miles from Waltham, MA)
- 25 days ago
- Boston, MA (10 miles from Waltham, MA)
- 25 days ago
Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services...
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...
guidelines Pay and Benefits The pay range for this position is $25.00 - $27.00/hr....
Senior Regulatory Affairs Specialist
- Canton, MA (16 miles from Waltham, MA)
- 60+ days ago
- Canton, MA (16 miles from Waltham, MA)
- 60+ days ago
About Us We are a leading regenerative medicine company in the advanced and acute wound care space and are always looking for exceptional talent. Join a company where you will have an opportunity...
- Devens, MA (20 miles from Waltham, MA)
- 60+ days ago
- Devens, MA (20 miles from Waltham, MA)
- 60+ days ago
Who We Are: At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented and diverse workforce in our industry. Our commitment to uncompromising...
Compliance Specialist, Cell Therapy Manufacturing (Cambridge, MA)
- Cambridge, MA (6 miles from Waltham, MA)
- 90+ days ago
- Cambridge, MA (6 miles from Waltham, MA)
- 90+ days ago
The Compliance Specialist provides support for projects, manufacturing execution, computer systems (GP, EBR, OpCenter APS), quality systems (deviations, change controls, CAPAs) and implementation...
Senior GCP Quality & Compliance Auditor
- Boston, MA (10 miles from Waltham, MA)
- 90+ days ago
- Boston, MA (10 miles from Waltham, MA)
- 90+ days ago
Trials, etc., Advanced technical knowledge in global regulations and industry standards as they apply to clinical research, medical devices and pharmaceuticals and in the conduct of clinical study...
Demographic Data for Waltham, MA
Moving to Waltham, MA? Find some basic demographic data about Waltham, MA below.
Quality Assurance Specialist Online Courses and Training Opportunities
Title Synonyms
Users interested in this job title also searched for the following job title
Salary for Quality Assurance Specialist Jobs in Waltham, MA
Required or preferred licenses and certifications for Quality Assurance Specialist positions.
Highest Education Level
Quality Assurance Specialists in Waltham, MA 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
- Water Quality
- Implementation
- 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
Other Career Titles
Here are some other career titles that require similar skills
Quality Assurance Specialist Related Career Advice Articles
4 Biotech Opportunities & Career Paths With High Growth Potential
Biotechnology is an emerging segment of the employment market with opportunities spanning healthcare, biopharmaceuticals, agriculture, industry, and academia. If you have a thirst for innovation, this career path might be right for you!
Read article »