Quality Assurance Lead

2 weeks ago

Seattle, Washington, United States Sunrise Systems, Inc. Full time

Job Title: Quality Assurance Manager

Company: Sunrise Systems, Inc.

Job Overview:

The Quality Assurance Manager plays a pivotal role in ensuring compliance and excellence within the quality management framework. This position is integral to the Manufacturing Sciences and Technology (MSAT) team, which is dedicated to the meticulous oversight of deviation records through an electronic quality record management system.

Key Responsibilities:

  • Lead investigations into No Impact, Minor, Major, and Critical deviations, identifying root causes and implementing corrective actions.
  • Ensure that all reports are comprehensive and meet regulatory standards.
  • Collaborate across departments to gather essential data for manufacturing and laboratory investigations.
  • Act as a champion for quality principles and compliance within the organization.

Qualifications:

  • Bachelor's degree in a relevant Science or Engineering discipline, or equivalent experience.
  • A minimum of 5 years of experience in a cGMP environment, with a preference for experience in FDA/EMA regulations in biotechnology or cellular therapy.
  • At least 2 years of experience managing quality systems, specifically with deviation and CAPA records.
  • Proven ability to author deviation and CAPA records with attention to detail.

Knowledge, Skills, and Abilities:

  • In-depth knowledge of GMP compliance and FDA/EMA regulations.
  • Exceptional written and verbal communication skills.
  • Ability to work collaboratively across functions and build strong relationships.
  • Innovative mindset with a commitment to quality and continuous improvement.
  • Strong problem-solving skills with the ability to anticipate challenges.

Additional Responsibilities:

  • Manage deviations to ensure timely closure and compliance with established timelines.
  • Facilitate investigation teams to define objectives and deliverables for CAPA initiatives.
  • Lead in-depth analyses of department-specific trends to identify and mitigate recurring issues.
  • Utilize both technical and interpersonal skills to drive the deviation and CAPA processes effectively.

This role is essential for maintaining the highest standards of quality and compliance within Sunrise Systems, Inc., and offers an opportunity to make a significant impact on the organization's success.

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