Quality Investigator - GMP

Description

Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates. Is knowledgeable and complies with all pertinent safety policies, rules and regulations. Ensure that all team members comply with safety rules and regulations. The Technical Investigator is responsible for the initiation, investigation and completion of process deviations, Change Controls, and CAPA’s for the assigned department.

The incumbent is responsible for completion of process deviations with the aim at identification of root cause, determining any product quality impact and implementation of corrective actions to prevent recurrence. They will also be responsible for drafting and managing Departmental Change Controls.

• Technical writing for the educated reader, translate moderate to complex scientific events into a brief and cohesive report as a finished product. Accurately capture immediate actions and containment of the event, address comments from both internal and external clients on the compiled final report.
• Gathering Data from various sources across the site, performance of Root Cause Analysis to determine the most likely cause of the deviation investigation, assessment of event for impact to Safety, Identity, Strength, Quality, Purity, perform trending analysis, identification of Corrective and Preventative Actions to reduce deviation recurrence, performance of Risk Assessments, Causing Mapping, Interviewing.
• Management of multiple projects and timelines concurrently. Ability to adhere to standard timeline and submit actions appropriately for resolution in a timely manner.
• Work with the appropriate department(s) for data gathering, observing processes for investigations, and performance of associate interviews.
• Meeting Facilitation and participation, aligning internal team and area subject matter experts on an agreed investigational path forward. Conflict resolution, problem solving in a cross functional setting, and ability to keep the meeting on track to achieve objective.
• Understand Regulatory requirements around Cell Therapy processing.

Gmp, Inspection, Capa, Document control, audit, investigation and analysis, root cause analysis, environmental monitoring, Sop, Fda, audit preparation, Pharmaceutical, Quality assurance, manufacturing quality, Reporting, Compliance

Gmp,Inspection,Capa,Document control,audit,investigation and analysis,root cause analysis,environmental monitoring

Undergraduate degree in a science discipline. 5+ years of experience in a cell therapy environment. Strong organizational and communication skills. Familiarity with cGMP quality systems and GMP documentation. Proficiency in Microsoft Office Suite. Ability to work independently and manage conflict resolution.

Expert Level

This is a Contract to Hire position based out of WINSTON SALEM, NC.

The pay range for this position is $40.00 - $45.00/hr.

• 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 WINSTON SALEM,NC.

This position is anticipated to close on Jan 30, 2026.

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 actalentaccom for other accommodation options.