Senior Quality Assurance Specialist

Senior Quality Assurance Specialist

Join to apply for the Senior Quality Assurance Specialist role at Sanguine Biosciences.

Sanguine Biosciences is accelerating personalized medicine research by empowering patients with their healthcare data and making it as easy as possible for them to participate in the medical research process. We partner with patients and pharmaceutical companies to accelerate precision medicine R&D by securely and efficiently collecting and providing patient samples and relevant health data. We are helping thousands of researchers at 20 of the top 40 global pharmaceutical and biotechnology companies increase the speed and quality at which they are conducting their research.

It is an exciting time; our biotech company is growing quickly and needs the best team members to join us.

This role is hybrid.

The Senior Quality Assurance Specialist is responsible, under Director level supervision, for leading, supporting, and ensuring continued suitability of the Quality Management System (QMS) with a primary focus on change control, systems validation, risk management, vendor management, deviation, complaint, and CAPA handling, internal auditing, and training.

• 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.

• 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.

• 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.

• Support the company training program by coordinating and scheduling training events
• Monitor and track employee training status; maintain employee training files

• 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.
• Regulatory Certifications such as ASQ / SQA certification and Six Sigma Black Belt preferred.
• Membership (national or local chapters) to SQA demonstrating Continuing Education
• Strong computer literacy skills.
• Excellent oral and written communication.
• Strong organization and time management is required.
• Proficient verbal communication skills are required.
• Autonomy and independence preferred.

$95,000 to $115,000 annually plus performance based bonus

Sanguine Biosciences is proud to provide equal employment opportunities to all qualified individuals without regard to race, color, religion, sex, gender identity, sexual orientation, pregnancy, age, national origin, physical or mental disability, military or veteran status, genetic information, or any other protected classification. Minorities, women, LGBTQ candidates, Veterans, and individuals with disabilities are encouraged to apply.

• Seniority level:
  Mid-Senior level
• Employment type:
  
  Full-time
• Job function:
  Quality Assurance