Quality Assurance Associate II (hybrid)

Posted 5 Days Ago
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Concord, CA
86K-105K Annually
1-3 Years Experience
Healthtech
The Role
The Quality Assurance Associate II is responsible for ensuring compliance with FDA regulations, ISO standards, and managing quality system deliverables. They lead audits, support supplier management activities, trend quality data, and assist in documentation for product release. They must possess strong problem-solving skills and attention to detail while adapting to changing priorities.
Summary Generated by Built In

About Cerus:

Cerus aims to be the global leader and trusted partner of blood centers and hospitals whose technology, services, and commitment are the lifeblood of safe and accessible blood for patients around the world.

Summary & Scope of Position: 

Primarily responsible for assuring compliance with regulatory requirements (FDA, MDD, MDR) and ISO standards for Class III combination products. Provide GMP and ISO 13485 compliance support as necessary. Support a wide array of activities related to Supplier Management, NCs, CAPAs and SCARs.

Primary Responsibilities:

  • Lead and track quality system deliverables to completion including NC/CAPA actions, internal audit findings, supplier audits, and actions from management reviews and data reviews.
  • Manage internal and supplier audit schedules and documentation.
  • Assist with the supplier management program, including supplier evaluations, performance monitoring, quality agreements, and audit tracking.
  • Trend quality data and update Key Process Indicators. Participate in analysis of data to identify trends and recommend improvements to improve quality.
  • Revise SOPs/INSs, route documents for approval, prepare flow charts and other quality documentation.
  • Identify compliance weaknesses and ensure the implementation of workable solutions.
  • Support documentation for product release.
  • Perform other related duties as required.

Qualifications/Requirements/Skills: 

  • Bachelor’s degree or equivalent in a scientific discipline
  • Minimum of 2 years’ quality assurance experience in a pharmaceutical or medical device industry.
  • General understanding of the FDA GMP regulations and ISO 13485; EU MDR experience is a plus.
  • Ability to exercise independent judgment and problem-solving skills.
  • Experience with documentation management systems and Enterprise Resource Planning (ERP) software is desired.
  • Familiarity with quality data review and technical writing.
  • Strong communication skills (encompasses verbal, written, interpersonal, listening).
  • High level of attention to detail and accuracy.
  • Flexible; ability to adapt to changing priorities.
  • Excellent time management skills (schedules, timelines, task prioritization)

We understand that our people are essential to our success.  This philosophy is revealed in our competitive benefits package, designed to improve employees’ lives both on and off the job.

Benefits plans: medical, dental, vision, domestic partner benefits, paid maternity and paternity leaves, healthcare and dependent care flexible spending, life and accidental death insurance, long-term and short-term disability insurance, matching 401(k), ESPP, RSUs

Work and family: EAP, legal and financial services, health club membership discounts, tuition reimbursement

Compensation: The base salary range for this position in the selected city is $86,000-$105,000 annually.  Compensation may vary outside of this range depending on various factors, including a candidate’s qualifications, skills, competencies, experience, and location. Base pay is one part of the total package to compensate and recognize employees for their work.


All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.  

The Company
HQ: Concord, California
361 Employees
On-site Workplace
Year Founded: 1992

What We Do

Cerus Corporation is dedicated solely to safeguarding the world’s blood supply and aims to become the preeminent global blood products company. Headquartered in Concord, California, the company develops and supplies vital technologies and pathogen-protected blood components to blood centers, hospitals, and ultimately patients who rely on safe blood. The INTERCEPT Blood System for platelets and plasma is available globally and remains the only pathogen reduction system with both CE mark and FDA approval for these two blood components. The INTERCEPT red blood cell system is under regulatory review in Europe, and in late-stage clinical development in the US. Also in the US, the INTERCEPT Blood System for Cryoprecipitation is approved for production of INTERCEPT Fibrinogen Complex, a therapeutic product for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. For more information about Cerus, visit www.cerus.com and follow us on LinkedIn.

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