Quality Assurance Specialist

2 days ago

Fremont, California, United States Asahi Kasei America Inc Full time
Job Title: Quality Assurance Specialist

Asahi Kasei America Inc is seeking a highly skilled Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring that products and processes meet established quality standards and regulatory requirements.

Job Summary:

The Quality Assurance Specialist will be responsible for conducting audits, implementing quality control procedures, and collaborating with cross-functional teams to enhance product quality and compliance. This role requires a strong understanding of cGMP regulations and guidance, as well as excellent analytical and problem-solving skills.

Key Responsibilities:
  • Conduct audits and inspections to ensure compliance with quality standards and regulatory requirements.
  • Implement quality control procedures and protocols to ensure product quality and safety.
  • Collaborate with cross-functional teams to identify and implement process improvements.
  • Develop and maintain quality documentation, including SOPs and training materials.
  • Provide training and support to staff on quality standards and procedures.
  • Monitor and analyze quality metrics and KPIs to identify trends and areas for improvement.
Requirements:
  • Bachelor's degree in life sciences, engineering, or a related field.
  • 3-5 years of experience working in a GMP environment with direct work on manufacturing, quality, process development, and/or quality control.
  • Experience working with cGMP regulations and guidance.
  • Excellent analytical and problem-solving skills.
  • Strong communication and interpersonal skills.
What We Offer:
  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • A dynamic and collaborative work environment.

Asahi Kasei America Inc is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating a workplace that is inclusive and respectful of all employees.

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