Analytical Quality Assurance Specialist

2 weeks ago


Thousand Oaks, California, United States Beacon Hill Full time

Position Overview: This role involves conducting analytical evaluations and providing support within the HPLC/Capillary Electrophoresis (CE) division of Clinical Quality Assurance.

This is a 1-year renewable contract position requiring onsite attendance during standard business hours.

Key Responsibilities:

  • Engage in various activities within Quality Control, including analytical evaluations, sample and data oversight, and equipment upkeep.
  • Execute standard laboratory procedures such as sample evaluations and preparation of standards and solutions.
  • Document, compile, analyze, review, and input laboratory data accurately.
  • Communicate findings effectively, operate specialized equipment, and draft/revise documents like Analytical Methods, SOPs, and technical reports.
  • Assist in the integration of new methodologies and techniques into the laboratory.
  • Conduct basic troubleshooting of assays and instruments.
  • Identify, suggest, and implement enhancements related to routine tasks.
  • Adhere to safety protocols and basic cGMP regulations.
  • Demonstrate flexibility in work schedules as necessary.
  • Be available for on-call duties as required.

Essential Qualifications:

  • Bachelor's degree with 2 years of experience in Quality Control, Quality Assurance, or a related field; OR an Associate degree with 6 years of relevant experience; OR a High school diploma/GED with 8 years of related experience.

Critical Skills Required:

  • Proficiency in HPLC and/or Capillary Electrophoresis methodologies.
  • Strong adherence to regulatory standards, documented procedures, and safety protocols.
  • Flexibility and adaptability to shifting priorities and requirements.

Desirable Qualifications:

  • Experience with HPLC and/or Capillary Electrophoresis techniques.
  • Ability to comply with regulatory standards and procedural documentation.
  • Capability to assess documentation/data in line with company and regulatory standards.
  • Strong organizational skills to manage multiple priorities and meet deadlines.
  • Excellent written and verbal communication abilities.
  • Attention to detail is essential.
  • Flexibility and adaptability to changing demands and priorities.
  • Understanding of regulatory standards, safety protocols, and compliance factors.
  • Ability to recognize when to escalate issues appropriately.


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