Quality Control Investigator

Stefanini Group is hiring!

Stefanini is looking for Quality Control Investigator in Davie FL

For quick Apply please reach out to Sahnaj Pervin - call:

/ email:

Work Hours:M-F (40 hours)

Work Location:Davie FL (Onsite)

Shift:1st Shift (8:00 AM - 5:00 PM)

This position is responsible for leading and performing cGMP investigations supporting Oral Solid Dose (OSD) manufacturing including complex manufacturing processes and equipment. The Investigator I authors and coordinates high-quality investigations for events occurring in Production Engineering Quality Control (QC) Laboratory and related support areas ensuring timely root cause identification appropriate product impact assessments and implementation of effective Corrective and Preventive Actions (CAPAs) to maintain compliant supply.

The role applies scientific and technical judgment to evaluate manufacturing and laboratory data interviews and observation equipment/utilities performance and process parameters to support robust root cause analysis and sustainable remediation for OSD unit operations (e.g. blending granulation compression coating encapsulation etc.) and associated systems.

Responsibility:

• Lead and/or co-author cGMP investigations for OSD manufacturing and complex operations (deviations/nonconformances/atypical events) ensuring clear problem statements accurate timelines and timely closure in the quality system.
• Coordinate event triage and immediate actions including containment and escalation and support batch disposition decisions with Operations Engineering QC and QA.
• Collect organize and analyze manufacturing engineering and laboratory evidence (e.g. batch records equipment/maintenance logs MES/SCADA/historian data calibrations environmental monitoring and test results) to establish event sequence and contributing factors.
• Facilitate cross-functional root cause analysis using structured tools (e.g. 5-Why fishbone fault tree as applicable) and document technically sound compliant conclusions and product impact assessments.
• Define document and track CAPAs (correction/corrective/preventive actions) with appropriate due dates and effectiveness checks; support on-the-floor verification and implementation to prevent recurrence.
• Prepare clear complete investigation/CAPA records; support trending and continuous improvement; and participate in audit/inspection readiness by providing evidence packages and responses (while maintaining required training and safe work practices).

Job Requirement:

• Masters or Ph.D. degree in a scientific or engineering discipline with relevant experience supporting investigations within pharmaceutical manufacturing engineering and/or QC laboratories; oral solid dosage (OSD) experience preferred.
• Experience using electronic quality systems and manufacturing/laboratory data systems (e.g. deviation/CAPA systems MES LIMS historian/trending tools AI tools) to support investigations trending and effectiveness monitoring preferred.

Skills Required:

• OSD manufacturing and complex process/equipment knowledge sufficient to investigate events across Production Engineering and QC (e.g. blending granulation compression coating encapsulation and supporting utilities).
• Strong Technical writing and documentation skills (deviations/nonconformances OOS/OOT as applicable product impact assessments CAPA and effectiveness checks) using Good Documentation Practices (GDP).
• Knowledge of cGMP pharmaceutical quality systems and data integrity expectations applicable to investigations CAPA and inspection readiness.
• Analytical and problem-solving capability using structured root cause analysis tools (e.g. 5-Why fishbone fault tree) to separate symptoms from true root causes.
• Ability to interpret and trend manufacturing/equipment/lab data using available systems and tools (e.g. eQMS MES LIMS historian/trending tools Excel/dashboards) to support risk-based decisions.
• Effective cross-functional facilitation and communication skills including managing multiple investigations aligning stakeholders and clearly presenting complex technical information.

Problem Solving:

• Proactively works on problems of a moderate to complex scope where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors.
• Seeks out all resources when selecting methods and techniques for obtaining results.
• Acts independently and proactively to recommend and administer methods and procedures for problem resolution.
• Able to identify solutions to general problems through collaboration and creativity.

Listed salary ranges may vary based on experience qualifications and local market. Also some positions may include bonuses or other incentives.

Stefanini takes pride in hiring top talent and developing relationships with our future employees. Our talent acquisition teams will never make an offer of employment without having a phone conversation with you. Those face-to-face conversations will involve a description of the job for which you have applied. We also speak with you about the process including interviews and job offers.

About Stefanini Group

The Stefanini Group is a global provider of offshore onshore and near shore outsourcing IT digital consulting systems integration application and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas Europe Africa and Asia and more than four hundred clients across a broad spectrum of markets including financial services manufacturing telecommunications chemical services technology public sector and utilities. Stefanini is a CMM level 5 IT consulting company with a global presence. We are CMM Level 5 company.

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