Quality Control Associate

2 days ago

Thousand Oaks, United States Beacon Hill Full time

Job Description: Quality Control Associate


Overview:

The Quality Control (QC) Associate plays a critical role in supporting microbiology laboratory operations under general supervision. This position involves performing routine microbiological testing, data documentation, and compliance with safety and regulatory guidelines.


Key Responsibilities:

  • Conduct routine microbiological laboratory procedures, including bioburden and microbial count testing, biological indicator testing, growth promotion testing, and media inspections.
  • Analyze environmental monitoring samples and ensure compliance with standard operating procedures (SOPs).
  • Document, compute, and enter data in Laboratory Information Management Systems (LIMS) or SmartLab (LMES) with accuracy.
  • Maintain specialized laboratory equipment and ensure preventive maintenance is performed on schedule.
  • Participate in investigations of out-of-specification results and support internal and external audits.
  • Support lab organization and cleanliness, including archiving documentation and preliminary plate readings.
  • Collaborate with team members to implement lab improvements and troubleshoot issues as they arise.
  • Maintain adherence to safety guidelines, cGMPs, and other regulatory requirements.


Qualifications Basic:

  • Bachelor’s degree in a relevant scientific discipline with one year of related experience; or an equivalent combination of education and experience.
  • Associate degree with six years of relevant experience; or a high school diploma/GED with eight years of related experience.


Preferred:

  • Experience with GxP practices in biopharmaceutical testing and familiarity with QC systems such as CDOCS (Veeva Vault), LIMS, and SmartLab.
  • Knowledge of data integrity requirements in QC processes.
  • Proficiency in Microsoft Office and excellent problem-solving capabilities.


Skills:

  • Strong written and oral communication skills.
  • Detail-oriented with the ability to manage multiple priorities and meet deadlines.
  • Flexibility and adaptability to changing requirements.
  • Understanding of regulatory compliance and safety guidelines.


Physical Requirements:

  • Ability to perform tasks requiring personal protective equipment and to lift/carry objects up to 15 pounds.
  • Frequent tasks include fine hand manipulation and desk-based computer work.


Working Conditions:

  • On-site work schedule of Monday to Friday, with potential weekend and holiday shifts based on operational needs.

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