Quality Assurance Associate III

Cerus•Concord, CA

2d•Hybrid

About The Position

Primarily responsible for assuring compliance with quality and regulatory requirements (FDA, MDD, MDR and MDSAP) and ISO standards with focus on ensuring high quality product and production continuity at suppliers with current and new Cerus products. Supports Warehouse and distribution Quality activities and batch release. Will provide GMP and ISO 13485 compliance support, as necessary.

Requirements

Bachelor’s degree or equivalent in a scientific discipline with a minimum of 5 years experience in a pharmaceutical or medical device industry OR Master’s degree with a minimum of 3 years experience.
Strong understanding of the GMP regulations and ISO 13485.
Ability to exercise independent judgment.
Strong communication skills (encompasses verbal, written, interpersonal, listening).
High level of attention to detail and accuracy.
Strong data review and technical writing skills.
Flexible; ability to adapt to changing priorities.
Excellent time management skills (schedules, timelines, task prioritization).

Nice To Haves

European Medical Devices Regulation (MDR) and MDSAP experience is a plus.
Ability to communicate in Spanish or French is a plus.
Ability to travel up to 20 % with some international travel.

Responsibilities

Work with suppliers to ensure compliance with raw material, in-process, and final product specifications. Create or update new specifications based on changes to the product and processes. Set quality requirements for Cerus and ensure that suppliers are adhering to requirements.
Provide on-site support at the supplier’s location for resolving production issues to ensure product quality and business continuity. Work on implementation, maintenance and continuous improvement of supplier related KPIs.
Create, review and approve Risk Assessments and Supplier Corrective Actions for deviations and non-conformances at suppliers. Lead discussions and decisions for the release of quarantined products based on Risk Assessments.
Participate in supplier and distributors evaluations, quality agreements and audits.
Perform batch release activities for raw materials, components, and final products by reviewing batch records and releasing on Cerus and suppliers’ software system.
Perform batch release activities for 3rd party products and spare parts.
Manage Oracle Transactions from a Quality Assurance standpoint.
Be the key liaison between Cerus and suppliers (mainly production and warehousing). Ensure cross-functional communication within Cerus and completion of tasks related to supplier controls.
Represent QA in the monthly and quarterly 3PL warehouse supplier meeting.
Provide training and guidance in the areas of government regulations to employees as well as to suppliers. Provide Quality training to suppliers/distributors if needed.
Help drive changes and improvements at suppliers for improving quality and product yield. Participate in continuous improvement projects. Establish and/or revise Key Process Indicators (KPIs) to help drive quality improvement projects (mainly for warehousing & distribution with Supply Chain and Customer Care)
Support Quality Management Systems and processes to ensure that the system effectively meets the objectives of the corporate quality policy and applicable standards and regulations.
Write/revise/review SOPs/INSs, prepare flow charts and other quality documentation, including investigation reports, audit reports, quality metric trend reports, etc.
Review and provide guidance for various non-conformance situations and CAPA investigation activities, evaluate root cause and corrective actions, and ensure documentation is complete, accurate, and closed in a timely manner.
Conduct internal audits to ensure that quality system requirements are met. Support external audits from the regulatory authorities.
Support change control projects and tasks.
Support risk management activities.
Review and approve verification and validation protocols and reports for equipment and manufacturing processes including sterilization.
Perform other related duties as required.