Quality Control Technician

7 hours ago

Santa Ana, United States Actalent Full time
Job DescriptionJob DescriptionJob Title: Quality Control Technician

Job Description

We are seeking a meticulous and dedicated Quality Control Technician to join our team. The successful candidate will be responsible for conducting quality control inspections and tests, assisting in document change procedures, and preparing and reviewing commercial batch records. This role requires experience in quality control within an aseptic fill operation and experience with FDA/cGMP standards.

Responsibilities
  • Conduct quality control inspections and tests.
  • Assist in document change procedures.
  • Prepare and document procedures, including commercial batch record preparation and review.
  • Conduct qualification and validation protocols, as assigned.
  • Assist with developing and writing qualification and validation protocols and reports.
  • Perform lab work as needed, including LAL, environmental monitoring, bioburden, sterility testing, and basic chemistry analysis.
  • Perform work within the quality systems, including process monitoring activities, reviewing and documenting instrumentation output, interacting with equipment systems, and laboratory record review.
  • Provide QA support, including non-conformance investigations.
Essential Skills
  • 2 years of quality control experience.
  • Proficiency in aseptic technique and aseptic fill operations.
  • 2 years of FDA experience.
  • Experience with laboratory and batch record review.
  • Bachelor of Science degree in a related field or comparable additional experience (Associates degree acceptable with 2 years of FDA quality experience).
Additional Skills & Qualifications
  • Pharmaceutical experience in an aseptic fill operation.
  • FDA/cGMP experience.
Work Environment

The candidate will be working between two different buildings located across the street from each other. They will be required to gown and assist with cleanroom activities, as well as gather QA documents in office spaces. This is a first shift opportunity with a flexible start time between 6am and 8am, requiring an 8-hour workday. Occasionally, the candidate may need to start as early as 4am.

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. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture 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

The company 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.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

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