Sr. Quality Assurance Associate

The Sr. QA Associate is a hybrid opportunity.

Summary & Scope of Position:

Primarily responsible for assuring compliance with regulatory requirements (FDA, MDD, EU MDR) and ISO standards. Will provide GMP, GLP, and ISO 13485 compliance support as necessary.

 Primary Responsibilities:

• Participate in development projects, providing support and guidance on design control activities including verification, validation, transfer, changes, design reviews, and risk management.
• Review manufacturing, QC, release records, and documentation.
• Perform internal and supplier quality audits and facilitate corrective actions.
• Review raw material, in-process, and final product specifications to evaluate and set quality requirements.
• Work with suppliers to ensure compliance with product specifications. Help drive changes and improvements at suppliers for improving quality.
• Review and provide guidance for various non-conformance situations and investigations activities, evaluate root cause and corrective actions, and ensure documentation is complete, accurate, and closed in a timely manner.
• Audit study reports and raw data for compliance with protocols, SOPs, and regulations.
• Write/revise/review SOPs/INSs as necessary.
• Identify compliance weaknesses and ensure the implementation of workable solutions.
• Perform other related duties as required.

Qualifications/Requirements/Skills: 

• Bachelor’s degree or equivalent in a scientific discipline with a minimum of 7 years’ experience in a pharmaceutical or medical device industry or Master’s Degree with a minimum of 5 years’ experience.
• Minimum 5 years’ experience in regulated operations.
• Strong understanding of the FDA GMP regulations and ISO 13485; GLP/GCP experience is a plus.
• Ability to exercise independent judgment.
• Strong data review and technical writing skills.
• High-level understanding of the scientific approach and analytical thinking of others.
• Strong communication skills (encompasses verbal, written, interpersonal, listening).
• Ability to influence others.
• 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 bay area is $124,000-$135,000 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.