Quality Assurance Specialist Jobs in Brookline, 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.
Delivers education to study staff on various topics including good clinical practice, research regulations and the conduct of clinical trials....
Research Regulatory Compliance Specialist Boston Children's Hospital
- Brookline, MA
- 5 days ago
- Brookline, MA
- 5 days ago
Delivers education to study staff on various topics including good clinical practice, research regulations and the conduct of clinical trials....
Research Regulatory Compliance Specialist
- Boston, MA (4 miles from Brookline, MA)
- 6 days ago
- Boston, MA (4 miles from Brookline, MA)
- 6 days ago
Delivers education to study staff on various topics including good clinical practice, research regulations and the conduct of clinical trials....
Quality Assurance Associate Director, CMO Management (Cell and Genetic Programs)
- Boston, MA (4 miles from Brookline, MA)
- 6 days ago
- Boston, MA (4 miles from Brookline, MA)
- 6 days ago
Job Description General/Position Summary The Associate Director, Quality Assurance is responsible for supporting the day-to-day Quality Operations of Contract Manufacturing Organizations (CMOs)...
- Westborough, MA (24 miles from Brookline, MA)
- 8 days ago
- Westborough, MA (24 miles from Brookline, MA)
- 8 days ago
Job Description: Compliance Specialist CMC Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver...
Senior GCP Quality & Compliance Auditor
- Boston, MA (4 miles from Brookline, MA)
- 8 days ago
- Boston, MA (4 miles from Brookline, MA)
- 8 days ago
As a technical expert in quality and compliance, the Senior Quality & Compliance Auditor plays a critical role in ensuring adherence to company policies, study protocols, GxP guidelines, and...
Regulatory Affairs Specialist, Biologics
- Tewksbury, MA (20 miles from Brookline, MA)
- 17 days ago
- Tewksbury, MA (20 miles from Brookline, MA)
- 17 days ago
Using unique expertise in the fields of materials science, surface science, optics, biochemistry and biology, the segment provides innovative solutions that improve productivity and enable breakthrough...
Regional Compliance Manager Americas
- Boston, MA (4 miles from Brookline, MA)
- 20 days ago
- Boston, MA (4 miles from Brookline, MA)
- 20 days ago
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Leica Microsystems, one of Danaher's 15+ operating...
Quality Systems & Regulatory Affairs Specialist, Digital Health
- Boston, MA (4 miles from Brookline, MA)
- 30+ days ago
- Boston, MA (4 miles from Brookline, MA)
- 30+ days ago
At WHOOP, we're on a mission to unlock human performance and health span. WHOOP empowers its members to perform at a higher level through a deep understanding of their bodies and daily lives....
- Cambridge, MA (4 miles from Brookline, MA)
- 30+ days ago
- Cambridge, MA (4 miles from Brookline, MA)
- 30+ days ago
Quality Compliance Specialist Job Description Job Title: Clinical Quality Compliance Lead Duration: 12 Months Location: Cambridge, MA (02142) - Hybrid role, 2 days per week on-site...
QA Senior Compliance Specialist, Night Time Operations
- Framingham, MA (15 miles from Brookline, MA)
- 45+ days ago
- Framingham, MA (15 miles from Brookline, MA)
- 45+ days ago
Job Title: QA Senior Compliance Specialist, Night Time Operations Location: Framingham, MA About the Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless...
SSGA Compliance Analyst, Assistant Vice President, Hybrid
- Boston, MA (4 miles from Brookline, MA)
- 45+ days ago
- Boston, MA (4 miles from Brookline, MA)
- 45+ days ago
Who we are looking for The SSGA Compliance team is looking to hire a Compliance Analyst, Assistant Vice President, to join the SSGA North America Compliance team. State Street Global Advisors...
- Boston, MA (4 miles from Brookline, MA)
- 60+ days ago
- Boston, MA (4 miles from Brookline, MA)
- 60+ days ago
DCAMM’S Mission The Division of Capital Asset Management and Maintenance (DCAMM) oversees over $2 billion in capital programs and projects, and is responsible for capital planning, project...
Clinical Trial Regulatory Affairs Specialist (Boston, MA)
- Boston, MA (4 miles from Brookline, MA)
- 60+ days ago
- Boston, MA (4 miles from Brookline, MA)
- 60+ days ago
Knowledge: Strong understanding of clinical trial regulations, Good Clinical Practice (GCP), International Council for Harmonization (ICH) guidelines, and ethical standards....
Inventory Control and SOX Compliance Manager
- Billerica, MA (16 miles from Brookline, MA)
- 60+ days ago
- Billerica, MA (16 miles from Brookline, MA)
- 60+ days ago
Lantheus is headquartered in Bedford, Massachusetts with offices in Canada and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has...
Demographic Data for Brookline, MA
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Salary for Quality Assurance Specialist Jobs in Brookline, MA
Highest Education Level
Quality Assurance Specialists in Brookline, MA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Quality Assurance Specialist position
- Verbal Communication
- Filing
- Environmental Compliance
- NEPA
- CERCLA
- Environmental Management
- Quality Systems
- ISO Certified
- Implementation
- Air Quality
- Inspections
- ISO 13485
- Clean Water Act
- Environmental Education
- Clean Air Act
- Natural Resource Management
- ISO 14001
- Certified Hazardous Materials Manager
- Reimbursement
- Internal Audits
- GxP
- 21 CFR 820
- Institutional Review Board
- ICH GCP
- Clinical Data Management
- Good Clinical Practice
- Gene Therapy
- ICH Guidelines
- Field Sampling
- Biology
- Ecology
- Pharmacovigilance
- Good Laboratory Practice
- Biotechnology
- Clinical Trials
- Clinical Research
- Environmental Science
- Genetics
- FDA Regulations
- Medical Device Sales
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- Standard Operating Procedures
- Engineering
- Affirmative Action
- Strategy Development
- Quality Control
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Reporting
- Education Experience
- Bachelor's Degree
- Microsoft PowerPoint
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Leadership
- Communication Skills
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