BioLegend ยท 1 month ago
Quality Assurance Coordinator
San Diego, CA
Full-time
Onsite
New Grad, Entry Level
$56K/yr - $62K/yr
0+ years expBioLegend is committed to providing researchers with high-quality reagents for life science research. The Quality Assurance Coordinator will play a vital role in the Quality Assurance team, performing QA activities, supporting the ERP system deployment, and ensuring compliance with quality systems procedures.
BioinformaticsBiotechnologyCollaborationHealth CareManufacturingMedicalNeurosciencePharmaceutical
Responsibilities
Acts in a support capacity for critical QMS processes such as, non-conformances, complaint management, field corrective actions, risk management, design control, CAPA, document and change control, training, batch release, auditing, supplier Management and validation
Reviews quality records for all related areas of responsibility
Demonstrates the ability to work with limited direction and can prioritize projects independently
Responsible for personal daily task management, training plans and performance management
Assist with generating, reviews and maintains QMS documents
Assist with monitoring and trending QMS elements and providing metrics data for monthly reports, quality objectives and key performance indicators (KPIs)
Assists with data preparation for Quality Management Reviews
Provides administrative support for external audits (regulatory or customer) and Internal Audits
Participates in the use of the eQMS system and expanded applications as appropriate
This position will interact with key internal stakeholders in Manufacturing, Facilities, IT, R&D, Customer Support and Supply Chain
Assist with monthly and management review data and metrics for areas of responsibility
Other projects or responsibilities as may be required
Qualification
Required
Bachelors in a scientific discipline or equivalent work experience
A minimum of 0-1 work experience in quality assurance. Experience with GMP/GLP or similar regulated products
Experience in MS Word, Excel, Powerpoint, Adobe Acrobat (PDF)
Associates Degree or equivalent work experience
A minimum of 2 years' work experience in quality assurance. Experience with GMP/GLP or similar regulated products
Experience in MS Word, Excel, Powerpoint, Adobe Acrobat (PDF)
Knowledge of standards and regulations such as MDSAP, ISO 13485 and country and region-specific regulations (i.e. FDA 21 CFR 820, EU IVDD)
Strong organization skills and attention to detail and accuracy
Self-motivated, able to multi-task, and work effectively in a fast-paced environment
Good communication and interpersonal skills
Ability to quickly analyze and solve problems
Preferred
IVD, MDSAP, ISO 13485 or similar compliance experience
Benefits
Medical, Dental, and Vision Insurance Options
Life and Disability Insurance
Paid Time-Off
Parental Benefits
Compassionate Care Leave
401k with Company Match
Employee Stock Purchase Plan
Company
BioLegend
BioLegend is a biotechnology firm that offers immunological reagents for biomedical research.
501-1000 employees
H1B Sponsorship
BioLegend has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (6)
2022 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2021-07-26Acquired
Leadership Team
Jessie HT Ni
Vice President Research And Development
Recent News
2025-05-06
Company data provided by crunchbase