Quality Control Investigation Analyst

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at are searching for the best talent for Quality Control Investigation Analyst to be located in Athens GA.

Purpose

Assists with data analysis and lab investigations. Supports data review and metrics reporting.

The Investigation Analyst is responsible for laboratory investigations including evaluation assessment and approval of nonconformance events related to Quality Control. The Quality Control investigation analyst leads and authors comprehensive investigations for laboratory issues Out of Specification/Out of Trend and atypical results 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 individual will also support initiatives and projects that drive continuous improvement and impact metrics and monitoring policies processes and standards.

Key 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.

Qualifications

Education:

• A minimum of an associate degree in science or bachelors degree in scientific or analytical discipline is preferred.

Experience and skills

Required:

• 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

Preferred:

• 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.

Other:

• This position may require availability for working multiple shifts including irregular (non-standard) shifts and/or weekends.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment as well as get a parents consent for the background check.

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