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Jobs · Analyst · California

Microbiology Laboratory Analyst II

Actalent · Hercules, CA · 2 mo ago
On-siteAnalyst$34–$53.65/hrContract

About the role

This client-facing position requires a hands-on Microbiology Laboratory Analyst to perform microbiology testing, manage samples, and support laboratory operations in a GMP/GLP-regulated environment. The role demands a strong quality mindset, excellent documentation skills, and the ability to perform both routine and advanced microbiological assays while maintaining strict compliance with regulatory and quality standards.

The role is based in a regulated laboratory environment that supports cGMP/GLP testing services in areas such as toxicology, biocompatibility, pharmacology, analytical chemistry, and microbiology. The position involves working extensively at the lab bench for up to 8 hours per day and standing for extended periods of time, up to 6 hours. The analyst regularly works in biosafety cabinets, laminar airflow units, and cleanrooms, and must be comfortable fully gowning to enter a sterility suite. The work includes repetitive motion tasks with hands and arms and requires the ability to lift up to 30 pounds.

Responsibilities

  • Perform microbiological testing in accordance with SOPs, GMP, GLP, USP, EP, and ISO requirements.
  • Conduct bioburden testing following USP guidelines.
  • Perform endotoxin testing in alignment with USP requirements.
  • Execute sterility testing according to USP standards.
  • Perform antimicrobial effectiveness testing following USP methods.
  • Conduct container closure integrity testing (CCIT).
  • Perform environmental monitoring of cleanrooms and controlled environments.
  • Conduct TOC, conductivity, and pH testing for water and utilities.
  • Support cleaning and disinfection validation activities.
  • Perform environmental monitoring and water/utility sampling as scheduled or requested.
  • Support method development, verification, validation, and method transfers.
  • Investigate out-of-specification (OOS) and non-conforming results and complete associated CAPA activities.
  • Maintain laboratory inventory, reagents, equipment, and associated documentation.
  • Ensure the laboratory remains compliant, clean, organized, and audit-ready at all times.
  • Deliver accurate and reliable test results within required turnaround times.
  • Support custom studies and client-specific projects as needed.
  • Collaborate with internal teams and clients to ensure clear communication of testing requirements and results.
  • Document all activities accurately and contemporaneously in accordance with regulatory and quality expectations.

Requirements

  • Minimum 2+ years of experience in a GMP/GLP or FDA-regulated laboratory environment.
  • Strong microbiology laboratory techniques and aseptic practices.
  • Hands-on experience with environmental monitoring.
  • Experience performing bioburden testing.
  • Proficiency working within cleanroom and controlled environments.
  • Excellent technical writing and documentation skills.
  • Strong attention to detail and a demonstrated commitment to quality.
  • Ability to thrive in a fast-paced, dynamic laboratory environment.
  • Ability to manage multiple tasks while maintaining accuracy and compliance.
  • Effective communication skills for a client-facing role.

Qualifications

  • BS, MS, or PhD in Microbiology, Biology, Biotechnology, Pharmaceutical Sciences, or a related scientific discipline preferred.
  • Experience supporting method development, verification, validation, and method transfers.
  • Familiarity with USP, EP, ISO, and other relevant regulatory and compendial standards.
  • Experience conducting cleaning and disinfection validations.
  • Background in working within cGMP/GLP testing services such as toxicology, biocompatibility, pharmacology, analytical chemistry, or microbiology.
  • Ability to participate in investigations, including OOS and non-conforming results, and support CAPA activities.
  • Bay Area location or ability to work on-site in the region preferred.
  • Motivation to contribute to a mission-driven organization focused on enhancing public health through testing services.
  • Adaptability to evolving workflows and modernized laboratory processes.

Pay

The pay range for this position is $34.00 - $53.65 per hour.

Benefits

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

  • Medical, dental, and vision
  • Critical Illness, Accident, and Hospital insurance
  • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
  • Life Insurance (Voluntary Life & AD&D for the employee and dependents)
  • Short and long-term disability
  • Health Spending Account (HSA)
  • Transportation benefits
  • Employee Assistance Program
  • Time Off/Leave (PTO, Vacation or Sick Leave)

Schedule

This is a Contract to Hire, fully onsite position based in Hercules, CA.

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