Quality Control Investigation Analyst

Johnson & Johnson Innovative Medicine•Athens, GA

1d•Onsite

About The Position

The Quality Control Investigation Analyst assists with data analysis and laboratory investigations, supporting data review and metrics reporting. This role is responsible for laboratory investigations, including the evaluation, assessment, and approval of nonconformance events related to Quality Control. The analyst leads and authors comprehensive investigations for laboratory issues, Out of Specification/Out of Trend, and atypical results events. In this role, the Analyst will lead, author, document, and drive formal investigations of process deviations, non-conformances, and incidents to determine root causes and ensure compliance with regulatory requirements and internal standards. As an investigation analyst, you will be responsible for interpreting data, analyzing results, identifying root causes, and defining corrective and preventive actions to aid in preventing recurrence in compliance with Good Manufacturing Practices and regulatory regulations. The individual will also support initiatives and projects that drive continuous improvement and impact metrics and monitoring policies, processes, and standards.

Requirements

A minimum of 2 years of experience in GMP manufacturing, specifically within a Quality Control or Quality Assurance role.
Hands-on experience with electronic Quality Management Systems for investigations
Excellent analytical, problem-solving, and decision-making skills.
Strong verbal and writing skills.
Ability to work in a team-oriented environment

Nice To Haves

Training in Technical Writing
Experience with laboratory information management systems (LIMS)
Prior work experience in pharmaceutical or FDA regulated quality environment
Strong investigative skills, including interviewing techniques and evidence collection.
Strong organizational and time-management skills, with attention to detail.

Responsibilities

Responsible for leading, documenting and closing investigations.
Own end to end investigations into Quality Control laboratory OOS/OOT events or other deviations/nonconformances related to laboratory procedures and processes.
Draft, edit and finalize investigation reports.
Responsible for ensuring investigations are following local procedures, processes and regulatory requirements (US FDA & ICH standards).
Ensure investigations meet internal timelines and regulatory expectations (e.g., timely initiation, risk assessment, and escalation; adherence to standard SOP timeframes).
Translate complex technical information into clear, accurate, and audit-ready reports that meet regulatory standards.
Perform thorough root cause analyses using formal tools (5 Whys, Fishbone/Ishikawa, Fault Tree) and document rationale and evidence supporting conclusions.
Coordinate and compile the appropriate information that can lead to finalizing the investigation report.
Develop, document, and track Corrective and Preventive Actions (CAPAs); ensure effectiveness checks are planned, executed, and documented.
Drive timely closure of investigations and CAPAs.