QC Microbiology Investigator II

The Quality Investigator/Scientist II works in a high-throughput, GMP-regulated environment, leading multiple quality investigations on behalf of QC testing groups, with a primary focus on QC Microbiology. This role drives timely completion of moderate-complexity investigations, supports continuous improvement and compliance initiatives, and collaborates closely with QA, QC, and cross-functional partners. The position combines hands-on investigative work, data-driven analysis, and training and mentoring responsibilities to strengthen overall quality and compliance within the organization.

Responsibilities

• Lead and manage multiple QC investigations simultaneously, primarily for QC Micro, ensuring thoroughness, accuracy, and on-time completion.
• Use TrackWise software to author, document, and manage investigations, including deviations, OOS, OOT, and CAPA records.
• Maintain a consistent record closure rate, averaging 3–4 deviation/OOS/CAPA record closures per month, adjusted for complexity.
• Conduct root cause analysis and develop effective corrective and preventive actions to address quality issues.
• Stay current with required training in internal learning systems and maintain training compliance at all times.
• Occasionally conduct RAPID meetings with QA and QC staff to review investigations, discuss findings, and align on next steps.
• Prepare and deliver compliance-related deliverables, including audit support, observation responses, and presentations to senior management and site leadership.
• Generate trend reports and analyze data to identify systemic weaknesses, recurring issues, and opportunities for process and quality improvement.
• Support and promote a strong compliance culture and assist leadership with implementing compliance and quality initiatives.
• Develop and deliver proactive and reactive training for the team to enhance investigative skills, compliance awareness, and process understanding.
• Assist with the development and refinement of tools, templates, and resources to improve the efficiency and effectiveness of the investigative process.
• Provide guidance and support to Scientist I and more junior investigators, sharing best practices and helping resolve complex issues.
• Complete overdue assessments and file record extensions as required to maintain accurate and compliant documentation.
• Author and revise standard operating procedures (SOPs) on a limited basis to reflect current practices and regulatory expectations.
• Assist in formulating and executing continuous improvement strategies and timelines related to investigations, QC Micro processes, and compliance.
• Participate in QC compliance activities related to audits, inspections, and internal quality reviews.
• Collaborate with internal stakeholders across QA, QC, and other functions to ensure alignment, transparency, and effective communication on investigation status and outcomes.
• Perform other related duties as assigned to support the broader quality and compliance objectives of the organization.

• Bachelor’s degree in a science-related field.
• Approximately 3–4 years of industry experience in a pharmaceutical FDA/GMP-regulated environment.
• Hands-on experience working in a QC Microbiologist or closely related QC Micro role.
• Experience with endotoxin testing, bioburden testing, and other USP compendial microbiological methods.
• Strong understanding of GMP regulations and their application in a QC laboratory setting.
• Knowledge of Good Laboratory Practices (GLP) and Good Documentation Practices (GDP).
• Proficiency in microbiology techniques, including aseptic technique.
• Experience conducting OOS/OOT investigations in a regulated environment.
• Ability to read, write, and communicate effectively in English, both verbally and in writing.
• Strong computer, scientific, and organizational skills to manage multiple investigations and tasks concurrently.
• Ability to use standard office and data tools such as MS Excel, Word, PowerPoint, SmartSheet, and PowerBI.
• Ability to work effectively in an evolving environment and adapt to changing priorities and internal customer needs.
• Strong communication skills, including active listening, facilitation, and appropriate escalation of issues.
• Ability to collaborate effectively with QA, QC, and cross-functional partners to resolve issues and drive improvements.

• Prior experience with TrackWise for quality investigations is highly beneficial.
• Experience with TapRooT or similar root cause analysis methodologies is a plus.
• Familiarity with environmental monitoring and laboratory operations is advantageous.
• Ability to inspire innovation and promote team effectiveness within the quality and QC Micro function.
• Demonstrated enjoyment of collaborative work, both within the department and with external partners.
• Interest in training, mentoring, and developing others in investigative and compliance practices.
• Comfort presenting investigation outcomes and trends to senior leadership and cross-functional stakeholders.

This role is primarily a first-shift position, working Monday through Friday. The position is based onsite, with all work performed onsite during the initial training period; after successful training, there is flexibility to work from home one day per week. The work involves significant desk and meeting time, requiring the ability to sit for extended periods while reviewing data, authoring investigations, and preparing reports and presentations. The role operates within a QC and laboratory-focused environment, requiring the use of appropriate personal protective equipment (PPE), including gloves and other laboratory-appropriate attire, when entering and working in laboratory spaces. You will work as part of a small, focused team, collaborating closely with a team of peers and a supervisor in a culture that emphasizes continual growth, learning, and professional development. The organization invests heavily in research and development and provides resources, tools, and systems such as TrackWise, SmartSheet, PowerBI, and standard office software to support high-quality, data-driven decision-making. This position offers the opportunity to convert to a full-time role based on performance and provides an environment that empowers individuals to make meaningful contributions to global health and quality outcomes.

Job Type & Location

This is a Contract to Hire position based out of Berkeley, MO.

The pay range for this position is $32.00 - $38.46/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)

This is a fully onsite position in Berkeley,MO.

This position is anticipated to close on May 15, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.