Quality Control Microbiologist - (Contract)

Quality Control Microbiologist (Contract)

Remote/Flexible Schedule | Sacramento, CA (Hybrid as Needed)
$35.00 - $50.00 per Hour DOE | 6-Month Contract (July - December)

Make an Impact in Next-Generation Cell Therapy

Are you a Quality Control Microbiologist looking for an opportunity to apply your GMP expertise while supporting innovative therapies that make a difference in patients' lives?

We are seeking a skilled Quality Control Microbiologist with 2-3+ years of experience in GMP-regulated environments within biotechnology, pharmaceutical, cell therapy, or life sciences. This six-month contract opportunity offers a flexible work schedule with primarily remote work and occasional onsite support in Sacramento, CA.

This role is ideal for a quality professional who enjoys problem-solving, investigating quality events, improving processes, and partnering with cross-functional teams to support cutting-edge manufacturing.

Why You'll Love This Opportunity

• $35.00 - $50.00 per hour DOE
• Approximately 6-month contract assignment (July through December)
• Primarily remote with flexible scheduling
• Opportunity to support innovative cell therapy manufacturing
• Work with a collaborative, mission-driven quality team
• Gain valuable experience supporting advanced therapies that impact patient care
• Partner with experienced professionals across Quality, Manufacturing, and Research teams

Required Experience

The ideal Quality Control Microbiologist will have:

• 2-3+ years of Quality Control Microbiology experience in a GMP-regulated environment
• Experience supporting biotechnology, pharmaceutical, cell therapy, or life sciences manufacturing
• Hands-on experience managing CAPAs (Corrective and Preventive Actions), including:
• Investigating quality issues
• Performing root cause analysis
• Implementing corrective actions
• Preventing recurrence through effective solutions
• Experience reviewing Environmental Monitoring (EM) deviations
• Experience reviewing Personnel Monitoring (PM) deviations
• Experience troubleshooting laboratory or manufacturing equipment
• Experience writing validation reports and supporting validation activities
• Working knowledge of FDA regulations, cGMP requirements, and Quality Management Systems (QMS)

Position Summary

The Quality Control Microbiologist plays a key role in maintaining quality systems and ensuring products meet regulatory and quality standards prior to release.

This position supports quality investigations, CAPA management, deviations, document control, validation activities, equipment troubleshooting, batch record review, and collaboration with Manufacturing, Quality Assurance, and Research teams.

Key ResponsibilitiesQuality Systems Management

• Manage and support quality systems including:
• Deviations
• Change Controls
• CAPAs
• Document Control
• Investigate quality events and perform root cause analysis
• Develop and document corrective and preventive actions
• Review and approve change controls
• Monitor completion of quality records and metrics
• Maintain inspection-ready quality documentation

Environmental & Personnel Monitoring

• Review Environmental Monitoring (EM) data and deviations
• Review Personnel Monitoring (PM) results and investigate quality events
• Support investigations and corrective actions related to monitoring programs
• Ensure compliance with GMP requirements

Equipment & Validation Support

• Troubleshoot laboratory and manufacturing equipment issues
• Support equipment qualification and validation activities
• Prepare, review, and maintain validation documentation
• Assist with continuous improvement initiatives

Batch Review & Product Release

• Review manufacturing batch records and supporting documentation
• Evaluate documentation for product release
• Support timely batch disposition decisions
• Partner with Manufacturing and Quality teams to ensure compliance with regulatory standards

Regulatory Compliance & Documentation

• Maintain compliance with FDA regulations and cGMP requirements
• Support internal and external audits
• Perform document reviews and maintain controlled quality records
• Ensure quality systems remain audit-ready

Training & Collaboration

• Serve as a quality resource for cross-functional teams
• Support training related to quality systems and compliance
• Promote a culture of continuous improvement and quality excellence

QualificationsRequired:

• Bachelor's degree in Biology, Biochemistry, Immunology, Microbiology, or related scientific discipline
• 2-3+ years of Quality Control, Microbiology, GMP Manufacturing, Analytical Development, Pharmaceutical, or Biotechnology Quality experience
• Strong understanding of FDA regulations, cGMP requirements, and Quality Management Systems
• Experience with:
• CAPA investigations
• Deviation management
• Validation documentation
• Equipment troubleshooting
• Quality documentation systems

Preferred:

• Cell therapy or biopharmaceutical manufacturing experience
• Batch record review and product disposition experience
• Environmental Monitoring (EM) experience
• Personnel Monitoring (PM) experience
• Internal audit experience
• Document Control system experience
• Quality Management Systems (QMS) experience

We're Looking For Someone Who Has

• Strong attention to detail and commitment to data integrity
• Excellent documentation and organizational skills
• Ability to manage multiple priorities in a fast-paced GMP environment
• Strong analytical and problem-solving abilities
• Excellent written and verbal communication skills
• Ability to work independently while collaborating with cross-functional teams

Work Environment

• Primarily remote work environment
• Flexible work schedule
• Occasional onsite support required at Sacramento facilities based on business needs
• Comfortable participating in virtual meetings and collaborating remotely
• Occasional overtime, weekend, holiday, or on-call support may be required

Physical Requirements

When onsite, must be able to:

• Meet cleanroom gowning requirements and wear required PPE
• Maintain compliance with GMP cleanroom standards
• Meet visual acuity requirements of 20/20 vision (corrected or uncorrected)
• Demonstrate normal color vision for inspection activities
• Follow requirements regarding PPE, cosmetics, jewelry, and gowning procedures

Compensation

$35.00 - $50.00 per hour DOE

Apply Today!

If you are an experienced Quality Control Microbiologist with GMP expertise, CAPA management experience, Environmental Monitoring knowledge, validation reporting skills, and a passion for advancing innovative cell therapies, we would love to hear from you.

Join a team where your quality expertise directly supports therapies designed to improve patients' lives.

Work Location: Hybrid Remote | Sacramento, CA 958

Pay: $35.00 - $50.00 per hour

Work Location: Hybrid remote in Sacramento, CA 95837