Investigator, MFG Compliance at ProKidney

Winston-Salem, North Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

26 Aug, 26

Salary

0.0

Posted On

28 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Root Cause Analysis, CAPA, Change Control, Technical Writing, Risk Assessment, cGMP, Cell Therapy, Deviation Investigation, Meeting Facilitation, Conflict Resolution, Microsoft Office Suite, Data Gathering

Industry

Biotechnology Research

Description

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 escalate 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. • Able to lead and track Change controls through the process ensuring timely completion. • Perform other duties as assigned. Requirements: Undergraduate degree in science discipline 5+ years’ experience in a Cell Therapy environment in the department hired. Strong organizational skills and record keeping with the ability to work overtime when needed. • Ability to engage and interview co-workers to obtain relevant information pertaining to investigations. • Strong attention to detail and organizational skills. • Strong communication skills (written and oral). • Independent and self-motivated. • Familiarity with cGMP quality systems. • Ability to read and comprehend GMP documents (i.e. SOPs, logs, and Batch Records). • Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, PowerPoint). ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Responsibilities

Responsible for initiating and completing process deviations, Change Controls, and CAPAs to identify root causes and prevent recurrence. The role involves technical writing of cohesive reports and collaborating with cross-functional teams to ensure product quality and regulatory compliance.