An innovative sterilization company in Novato, CA is seeking a dedicated and detail-oriented Quality Assurance Manager to join their growing team! This role is crucial for ensuring that the company’s products meet the highest standards of quality and regulatory compliance. They are looking for candidates with a strong background in Quality Assurance within a regulated industry, a passion for continuous improvement, and a commitment to maintaining the highest of standards. The role involves overseeing multiple projects, collaborating closely with the operations department, and ensuring compliance with cGMP and ISO 13485 standards. This is a perfect opportunity for a professional who is passionate about quality, values autonomy, and is eager to grow and make a meaningful impact! 

Salary Range: $38 – $48 / hour DOE

Quality Assurance Specialist Requirements

• Bachelor’s degree (BS) in Biological Science or a related field, or equivalent experience
• 5+ years of Quality Assurance experience in a regulated industry
• Extensive experience with GMP documentation
• Strong working knowledge of 21CFR Part 820 and ISO 13485
• Proficiency in using MS 365
• Excellent attention to detail, organizational skills, and the ability to manage multiple projects simultaneously
• Strong communication skills and the ability to work collaboratively in a team environment

Quality Assurance Specialist Responsibilities:

• Manage multiple projects, working closely with the operations department to continuously update project statuses
• Respond to customer inquiries via email, phone, and Teams/Zoom meetings
• Implement and enforce company procedures in compliance with regulatory requirements
• Oversee validation processes, lot releases, requalifications, and adoptions for accuracy
• Review production and quality control documents to ensure compliance with company procedures, cGMP, and ISO 13485
• Maintain and manage the document control system
• Execute and manage non-conformances, CAPAs, customer feedback, and complaint reports
• Write, revise, and review SOPs, work instructions, specifications, protocols, and reports
• Represent the company with a high level of integrity and professionalism
• Adhere to company policies and support management decisions in a positive and professional manner
• Perform other QA/QC-related tasks as assigned
• Assist the General Manager as needed
• Conduct batch records review
• Perform incoming materials inspections
• Conduct equipment validations, calibrations, and monitor scheduled maintenance
• Print and distribute hard or PDF copies of production records for customers
• Evaluate and approve suppliers to ensure quality standards

Benefits:

• Full medical coverage for employees
• 401K Plan with match
• 15 days PTO + Paid holidays
• Relaxed yet focused work environment

If you are passionate about quality and compliance and enjoy working in a collaborative and supportive environment, this is a fantastic opportunity that you don’t want to miss. Apply now!

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