Job Description

Job Description

Job Description

Job Title: Compliance Investigator

Job Description

We are seeking a dedicated Investigator responsible for writing and completing investigations and deviations from both a compliance and operations perspective. This role involves conducting root cause analysis, overseeing the full lifecycle of investigations, and ensuring adherence to GMP standards.

Responsibilities

• Write and complete investigations and deviations to ensure compliance with manufacturing and GMP standards.
• Conduct root cause analysis and manage the full lifecycle of investigations independently.
• Interview manufacturing personnel and communicate effectively with vendors regarding investigations.
• Own and author deviations, determining causes and preventative actions for deviations, non-conformances, OOS, OOT, field complaints, and environmental excursion investigations.
• Drive investigations to true root cause using appropriate tools and benchmark industry standards.
• Define and implement effective preventative actions to prevent recurrence.
• Manage multiple investigations at different stages to meet compliance deadlines and product release dates efficiently.
• Collaborate with cross-functional teams to develop and track CAPA plans.
• Identify and create trending rules that trigger corrective actions.
• Analyze process data and evaluate trends to identify improvement opportunities.
• Develop training materials and educate personnel on writing problem statements and using root cause analysis tools.
• Champion CAPA plans and their implementation.
• Provide communication plans for ongoing deviations and CAPA's.
• Oversee timely completion of deviations, CAPAs, and Change Controls as necessary.

Essential Skills

• 2-3 years of experience writing and reviewing deviations and investigations.
• Experience working within a pharmaceutical company supporting manufacturing.
• Experience within a quality assurance team.
• Strong skills in root cause analysis and CAPA.
• Experience in GMP Operations and/or Quality Assurance in Cell Therapies, Biotechnology, or Bio-Pharma.

Additional Skills & Qualifications

• Bachelor's degree in a related scientific field.
• Experience with biologics, aseptic techniques, and manufacturing environments.
• Technical writing proficiency.
• Experience using e-Quality Management Systems.
• Proficiency with IT skills, including Visio, Microsoft Project, and Excel.

Work Environment

You will work closely with a team of QA/QC professionals and cross-functionally with the manufacturing team. The team currently consists of 2-3 other investigators. You will work on the first shift, Monday through Friday, with an 8am or 9am start time, across two sites located a block away from each other. The role offers opportunities for growth, a positive work culture, and the satisfaction of contributing to 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 $45.00 - $45.00/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 11, 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 actalentaccommodation@actalentservices.com for other accommodation options.

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