QC Microbiologist

Job Title: Specialist, Quality Control - Microbiologist, must have validation experience and writing the reports.

M-F DAY shift 7 am to 3:30 pm.

First couple of weeks onsite, then remote.

Job Description

This contract Quality Control Microbiologist role plays a critical part in supporting high-precision cell therapy manufacturing by overseeing key quality systems and ensuring that products meet rigorous regulatory and internal standards before release. Based on-site in Sacramento, CA, the specialist manages deviations, change controls, CAPAs, and document control, while contributing to batch disposition decisions that directly impact patients receiving next‑generation cell therapies. The position offers approximately six months of maternity leave coverage, working in a fast‑paced, highly regulated environment where scientific excellence, data integrity, and collaboration are central to the mission.

Responsibilities

• Oversee the management of quality systems, including deviations, change controls, CAPAs, and document control, ensuring they operate effectively and in compliance with internal procedures.
• Investigate deviations thoroughly and in a timely manner, identify root causes, and implement effective corrective and preventive actions.
• Review and approve change controls to ensure alignment with regulatory requirements and established quality standards.
• Maintain and continuously improve CAPA processes to drive effective resolution of quality issues and prevent recurrence.
• Evaluate batch records and associated documentation to make informed batch release decisions in support of rapid processing timelines.
• Collaborate closely with manufacturing and quality control teams to ensure all products meet regulatory and quality standards prior to release.
• Monitor, document, and address any quality issues related to batch production, implementing corrective measures as needed.
• Maintain the document management system so that all quality-related documents are accurate, current, and compliant with regulatory expectations.
• Conduct regular reviews of quality documentation to confirm adherence to established protocols and procedures.
• Stay current on applicable FDA regulations, GMP requirements, and industry best practices in pharmaceutical and cell therapy quality assurance.
• Assist in preparation for internal and external audits, ensuring that quality systems and documentation remain audit‑ready.
• Provide training and guidance to staff on quality systems, processes, and compliance requirements, supporting a strong culture of quality.
• Serve as a point of contact for quality-related inquiries and issues, offering clear direction and support to cross‑functional partners.
• Participate in continuous improvement initiatives to enhance the effectiveness and efficiency of quality systems and processes.
• Identify areas for improvement within quality operations, propose appropriate solutions, and help implement agreed‑upon changes.
• Track completion of quality records, maintain metrics, and report on key quality performance indicators as required.
• Perform internal audits and support document control management activities to strengthen compliance and data integrity.
• Carry out additional duties as requested to support overall Quality objectives and regulatory compliance.
• Work collaboratively with cross-functional teams, including manufacturing, research and development, and quality assurance, to support the overall quality of cell therapy products.
• Communicate effectively with team members and contribute to a positive, collaborative work environment.
• Actively participate in group and project teamwork, including project and process improvement initiatives.
• Adhere to cGMP policies and procedures, including meticulous documentation practices and proper use of personal protective equipment.
• Meet project and testing timelines while managing multiple tasks concurrently in a dynamic setting.
• Provide on‑call support outside regular business hours as needed and work overtime when required to meet business needs.

Essential Skills

• Bachelor's degree in a relevant scientific discipline such as biology, biochemistry, immunology, or a related field with 3+ years of experience in quality control testing, analytical development, or GMP; or a Master's degree in a relevant scientific discipline with 1+ years of experience.
• Hands-on experience in quality control or GMP operations, preferably within a cell therapy or biopharmaceutical manufacturing environment.
• Strong understanding of FDA regulations, GMP compliance requirements, and quality system processes.
• Demonstrated experience managing deviations, change controls, CAPAs, and document control within a regulated environment.
• Experience running validation activities and handling CAPAs, including authoring or reviewing validation reports.
• Knowledge of environmental monitoring and quality control methodologies in a pharmaceutical or biotechnology setting.
• Proven ability to meet project and testing timelines while maintaining high standards of quality and compliance.
• High level of attention to detail with a strong commitment to data integrity and accuracy, including the ability to identify and resolve data management issues.
• Ability to work both independently and collaboratively within a multi‑disciplinary team in a fast‑paced, highly regulated environment.
• Strong organizational skills with the ability to manage multiple tasks concurrently and adapt to changing priorities and challenges.
• Effective verbal and written communication skills, with the ability to convey complex quality concepts clearly to diverse stakeholders.
• Ability to adhere to cGMP policies and procedures and to wear appropriate personal protective equipment in production and cleanroom areas.
• Willingness and ability to work scheduled overtime, weekends, or holidays as required by business needs, and to provide on‑call support outside regular business hours.

Additional Skills & Qualifications

• Prior experience performing internal audits and supporting document control management in a GMP or FDA‑regulated environment.
• Experience with validation planning, execution, and reporting for quality control systems or equipment.
• Experience with environmental monitoring programs and related quality oversight within manufacturing or laboratory settings.
• Familiarity with CAPA management tools and electronic quality management systems.
• Exposure to cell therapy or advanced biologics manufacturing processes and associated quality control testing.
• Ability to contribute to continuous improvement initiatives, including process optimization and system enhancements.
• Comfort working in a fast‑paced, entrepreneurial environment with evolving processes and responsibilities.
• Demonstrated willingness to learn new technologies and approaches in support of innovative cell therapy development.
• Approximately six‑month availability to provide maternity leave coverage in a contract or consultant capacity.

Job Type & Location

This is a Contract position based out of Sacramento, CA.

Pay and Benefits

The pay range for this position is $40.00 - $50.00/hr.

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 & vision
• Critical Illness, Accident, and Hospital
• 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)

Workplace Type

This is a hybrid position in Sacramento,CA.

Application Deadline

This position is anticipated to close on Jul 28, 2026.

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.

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.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.