QA Investigator

Job Title: QA InvestigatorJob Description

We are seeking a dedicated QA Investigator to join our team. The role involves writing and completing investigations and deviations, ensuring compliance from both compliance and operations perspectives. The ideal candidate will conduct root cause analysis and manage the entire lifecycle of investigations independently, communicating effectively with vendors and manufacturing teams.

Responsibilities

• Determine the causes and preventative actions of Deviations, Non-Conformances, Out of Specification (OOS), Out of Trend (OOT), field complaints, and environmental excursion investigations.
• Drive investigations to true root cause using appropriate investigation tools and benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets.
• Define and implement effective preventative actions to prevent recurrence.
• Manage multiple investigations in different stages to efficiently meet compliance deadlines and product release dates.
• Collaborate with cross-functional teams to develop and track Corrective and Preventive Action (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 and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy, and deviation processes.
• Champion CAPA plans and implementation.
• Provide communication plans for ongoing deviations and CAPAs.
• Create and communicate CAPA plans effectively to responsible parties.
• Oversee timely completion of deviations, CAPAs, and Change Controls as necessary.
• Abide by quality standards.

Essential Skills

• 2-3 years of experience writing and reviewing deviations and investigations.
• Experience within a pharma company supporting manufacturing.
• Previous experience within a quality assurance team.
• Bachelors degree within a related scientific field.
• Experience in GMP Operations and/or Quality Assurance in Cell Therapies, Biotechnology, or Bio-Pharma.
• Root cause analysis experience in pharmaceutical or FDA regulated operations.
• Relevant IT skills, including proficiency with Visio, Microsoft Project, and Excel.

Additional Skills & Qualifications

• Experience using e-Quality Management Systems.
• Experience with CAPA and GMP.
• Knowledge of biopharma/biotech and biologics.
• Technical writing skills.
• Experience with cell and gene therapy.

Work Environment

The QA Investigator will work closely with quality assurance and a team of QA/QC professionals on a daily basis, collaborating cross-functionally with the manufacturing team. The role is based at two sites located a block apart, and the team currently includes five other investigators. The position operates on a first-shift schedule from Monday through Friday, with start times at either 8 am or 9 am. The company offers a supportive work culture with opportunities for growth and expansion, focused on saving patients' lives.

Job Type & Location

This is a Contract to Hire position based out of Allendale, New Jersey.

Pay and Benefits

The pay range for this position is $40.00 - $46.00/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 fully onsite position in Allendale,NJ.

Application Deadline

This position is anticipated to close on Sep 19, 2025.

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 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 actalentaccommodation@actalentservices.com for other accommodation options.