Quality Assurance Specialist

2 days ago


Santa Ana, California, United States Actalent Full time
Job Title: Quality Assurance Technician

About the Role:

We are seeking a highly motivated and detail-oriented Quality Assurance Technician to join our team at Actalent. As a Quality Assurance Technician, you will be responsible for ensuring the quality of our products and services by reviewing and editing batch records, assisting in Document Change Control, and reviewing history records for compliance.

Key Responsibilities:

  • Review and edit batch records to ensure accuracy and completeness
  • Assist in Document Change Control and review history records for compliance
  • Work with Non-conformances, discrepancies, and dispositions
  • Assist with investigations for Environmental Monitoring - surface sampling, air sampling, etc.
  • Perform lab work as needed within microbiology and chemistry
  • Perform OS investigations
  • Assist with work within quality systems as needed, including supplier management, internal audits, non-conformances, and risk analysis
  • Assist with handling customer complaints and support regulatory audits

Requirements:

  • Bachelor of Science degree in a related field or comparable additional experience
  • Associates okay with 2 years of FDA quality experience, Bachelors at least 1 year
  • Pharmaceutical experience preferred
  • FDA/cGMP Experience - 1 year
  • Experience with Microsoft Office suite
  • Master control experience is preferred

About Actalent:

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation, and speed to market.

Diversity, Equity & Inclusion:

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. We are committed to creating an inclusive environment through:

  • Hiring diverse talent
  • Maintaining an inclusive environment through persistent self-reflection
  • Building a culture of care, engagement, and recognition with clear outcomes
  • Ensuring growth opportunities for our people

Equal Opportunity Employer:

Actalent is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information, or any characteristic protected by law.



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