Job Title: Compliance Investigator

Job Description

We are seeking a skilled Compliance Investigator to join our team. In this role, you will be responsible for writing and completing investigations and deviations from a compliance and operations perspective. You will review investigations to ensure manufacturing and GMP compliance, conduct root cause analyses, and manage the entire lifecycle of investigations independently. Strong technical writing and communication skills are essential as you will interview manufacturing personnel and liaise with vendors during investigations.

Responsibilities

• Determine the causes and preventative actions for Deviations, Non-Conformances, OOS, OOT, field complaints, and environmental excursion investigations.
• Drive investigations to true root cause using appropriate investigation tools and benchmark industry standards.
• Define and implement effective preventative actions to prevent recurrence.
• Manage multiple investigations in 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 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 using root cause analysis tools, discrepancy, and deviation processes.
• Champion CAPA plans and implementation.
• Provide communication plans for ongoing deviations and CAPAs.
• Effectively create and communicate CAPA plans to responsible parties.
• Oversee timely completion of deviations, CAPAs, and Change Controls as necessary.
• Ensure adherence to quality standards.

Essential Skills

• 3-5 years of experience writing and reviewing deviations and investigations.
• 3-5 years of experience working within a pharma company supporting manufacturing.
• Previous experience within a quality assurance team.
• 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.
• Experience using e-Quality Management Systems.
• Relevant IT skills (Visio, Microsoft Project, and Excel).

Additional Skills & Qualifications

• Bachelor's degree in a related scientific field.
• Experience writing and reviewing investigations and deviations.
• Experience working with quality assurance to ensure all investigations are accurately tracked and documented from an operations standpoint.
• Experience in CAPA, GMP, Biopharma/biotech, cell and gene, or biologics.
• Strong technical writing skills.
• Ability to independently open and close investigations.
• Proficiency in life cycle management and root cause analysis.

Work Environment

You will be part of a growing company with a good work culture, dedicated to saving patients' lives. You will have exposure to new technical writing techniques and work closely with cross-functional departments daily. There are opportunities for internal growth, and you will be part of a team reporting directly to the VP.

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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are 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

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.

Salary : $50 - $55