Demo

Quality Assurance Expert

Randstad Life Sciences US
Berkeley, CA Full Time
POSTED ON 2/25/2025
AVAILABLE BEFORE 5/17/2025

Join a Leading Health and Nutrition Company

Become a key player in one of the world's foremost companies dedicated to innovations in healthcare and agriculture. Help create a future where diseases are effectively prevented and treated. Join a team united by the vision of 'Science for a better life.'

Position Summary

As a Quality Assurance Expert, your primary focus will be on internal processes. You will lead cross-functional teams and collaborate with external partners on tasks related to deviation and change management. Your effective communication at all organizational levels will support department objectives and management strategies.

Key Responsibilities

Your duties will include :

  • Reviewing electronic batch records and collaborating with QA and operations staff.
  • Identifying errors within the batch records and liaising with production to ensure timely corrections are made for API and drug substance batch releases.
  • Handling paper batch records, which represent a smaller portion of your reviews (approximately 10%).
  • Assisting team members with archiving paper records.
  • Being part of a supportive and knowledgeable team that provides diverse insights and expertise.
  • Ensuring the release of safe and effective products for the global community.

Skills and Qualifications

  • Bachelor's degree in a scientific or technical field.
  • Minimum of 7 years of relevant experience in the biopharmaceutical, biologics, or medical device industries, along with a solid understanding of cGMP concepts and applicable regulations.
  • At least 4 years of hands-on experience in Manufacturing and / or Quality in a GMP-regulated environment.
  • Experience reviewing and approving pharmaceutical manufacturing electronic and paper batch records.
  • Prior work experience in Quality Assurance, especially in releases, is preferred.
  • Proven ability to be both a team player and a leader.
  • Excellent interpersonal and communication skills.
  • Ability to listen, understand, and influence stakeholders without direct authority.
  • Strong capability to work independently and as part of a team.
  • Proficiency in multitasking and adapting to changing priorities.
  • The ability to plan, prioritize, and address complex objectives effectively.
  • In-depth knowledge of GMP standards.
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