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Sanguine Biosciences · 3 days ago

Senior Quality Assurance Specialist

Los Angeles, CA

Full-time

Hybrid

Senior Level

$95K/yr - $115K/yr

5+ years exp

Sanguine Biosciences is accelerating personalized medicine research by empowering patients with their healthcare data. The Senior Quality Assurance Specialist is responsible for leading and ensuring the suitability of the Quality Management System, focusing on change control, risk management, and compliance-related activities.

AppsBiotechnologyClinical TrialsHealth CareLife ScienceMedical

Growth Opportunities

Responsibilities

Maintaining process and creating associated QMS:

Promote awareness of the Quality System and provide training to individuals across the organization on quality management principles, tools, techniques and best practices

Support the implementation of corporate policies and procedures relating to quality, design control, risk management, project management, process development, supplier management and FDA/ISO compliance

Compile and report quality metrics

Engineer solutions to address product and process quality issues

Support the document control and training system

Handling Internal quality inputs:

Work as an individual as well as part of a team to drive forward continual improvement initiatives and address compliance challenges

Lead the investigation, reporting, and resolution of customer complaints, deviations and CAPAs

Audits:

Conduct supplier audits and host or co-host client audits

Support the annual audit program; manage, schedule, perform and report on internal, external and supplier audit activity

Training:

Support the company training program by coordinating and scheduling training events

Monitor and track employee training status; maintain employee training files

Qualification

Quality Management SystemRegulatory CertificationsClinical Research ExperienceSix Sigma Black BeltAuditing SkillsAutonomyCommunicationTime Management

Required

Bachelor's Degree in Biology, Chemistry, Life Sciences or Engineering, required

At least 5 years of experience in a quality role supporting clinical research, or pharmaceutical development. Note: An advanced degree in Biology, Chemistry or Life Sciences may be accepted in lieu of some professional experience

Strong computer literacy skills

Excellent oral and written communication

Strong organization and time management is required

Proficient verbal communication skills are required

Preferred

Regulatory Certifications such as ASQ / SQA certification and Six Sigma Black Belt preferred

Membership (national or local chapters) to SQA demonstrating Continuing Education

Autonomy and independence preferred

Company

Sanguine Biosciences

Sanguine Biosciences is accelerating personalized medicine by empowering patients with their healthcare data and facilitating participation in biomedical research.

Founded in 2010

Woburn, Massachusetts, USA

51-200 employees