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MS&T Specialist – Deviations Investigator
ICONMA, LLC
🇺🇸 United States
On-site
5 months ago
- triage
- SCADA
- CAPA
- Technical Writing
- Excel
5 months ago
Responsibilities:
- All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.
- 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).
Requirements:
- Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.
- Master’s 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
- 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.
- 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.
- This role will focus heavily on internal troubleshooting within Client and require frequent cross-functional collaboration. The individual should be confident in navigating conversations across teams, with strong negotiation skills and the ability to communicate effectively and proactively.
- Minimum Master’s degree
Why Should You Apply?
- Health Benefits
- Referral Program
- Excellent growth and advancement opportunities
ICONMA is an Equal Opportunity Employer. All qualified applicants will receive considerationfor employment without regard to any status protected by applicable law.
MS&T Specialist – Deviations Investigator · ICONMA, LLC