QC Microbiology Compliance Investigator

Job Description

Job Description

Job Title: QC Microbiology Compliance Investigator

Job Description

As a QC Microbiology Compliance Investigator, you will play a pivotal role in determining the causes and preventative actions of Deviations, Non-Conformances, Out of Specifications (OOS), Out of Trends (OOT), and environmental excursion investigations. You will drive investigations to their true root cause using appropriate tools, benchmark industry standards, and implement investigative and impact assessment toolsets. Your work will define and implement effective preventative actions to prevent recurrence while managing multiple investigations efficiently.

Responsibilities

• Collaborate with cross-functional teams to develop and track CAPA plans.
• Identify and create appropriate trending rules that trigger corrective actions.
• Analyze process data and evaluate trends to identify major improvement opportunities.
• Effectively utilize change management approaches.
• Develop materials to train personnel on writing problem statements and using root cause analysis tools.
• Manage CAPA plans and their implementation.
• Communicate plans for ongoing deviations and CAPAs effectively.
• Oversee the timely completion of deviations, CAPAs, and Change Controls.
• Abide by quality standards and ensure compliance.

Essential Skills

• Expertise in laboratory processes, CAPA, Bioburden, and Aseptic techniques.
• Experience in investigations and analysis, including life-cycle investigations of deviations and non-conformances.
• GMP Training, Quality Systems Training, and Safety Training.
• Experience with QC Micro deviations and compliance in microbiology.
• Knowledge of U.S. and international cGMPs, ICH, and other regulations.

Additional Skills & Qualifications

• Bachelor of Science in a Quality/Process-related field or equivalent experience.
• 3-5 years of experience in quality control or assurance within the bio-pharma, biologics, or pharmaceutical industry.
• Experience leading event investigations, Root Cause Analysis (RCA), and CAPA.
• Technical experience in writing and assessing deviations, investigations, and OOS.
• Strong IT skills, including proficiency with Visio, Microsoft Project, and Excel.
• Experience using e-Quality Management Systems is preferred.

Work Environment

You will work in a GMP Commercial Facility with a schedule of Monday to Friday on the 1st shift. Flexibility is essential. The work environment offers a great atmosphere, opportunities for growth, and the chance to be part of a new project taking a client's product commercial.

Pay and Benefits

The pay range for this position is $45.55 - $45.55/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 fully onsite position in Allendale,NJ.

Application Deadline

This position is anticipated to close on Nov 3, 2025.

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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 due to a disability, please email [email protected] for other accommodation options.