Senior Quality Assurance Specialist

Sanguine Biosciences, Inc.•Los Angeles, CA

3d•$95,000 - $115,000

About The Position

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.

Requirements

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.
Autonomy and independence preferred.

Nice To Haves

Regulatory Certifications such as ASQ / SQA certification and Six Sigma Black Belt preferred.
Membership (national or local chapters) to SQA demonstrating Continuing Education

Responsibilities

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