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Deviation Investigations Specialist

Sunrise Systems Inc

Davie, FL

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JOB DETAILS
SKILLS
Analysis Skills, Artificial Intelligence (AI), Communication Skills, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Analysis, Documentation, Drug Manufacturing, Environmental Monitoring, Equipment Maintenance/Repair, Event Management, Identify Issues, Laboratory, Laboratory Equipment, Laboratory Information Management System (LIMS), Manufacturing, Manufacturing Analysis, Manufacturing Operations, Manufacturing Systems, Manufacturing/Industrial Processes, Negotiation Skills, Problem Solving Skills, Procedure Implementation, Quality Assurance, Quality Control, Reporting Dashboards, Risk, Root Cause Analysis, Safety/Work Safety, Structured Analysis, Supervisory Control and Data Acquisition (SCADA), Technical Presentation, Technical Writing, Testing, Time Management, Writing Skills
LOCATION
Davie, FL
POSTED
23 days ago
Job title: Deviation Investigations Specialist
Job ID: 26-02384
Location: Davie, FL, 33314
Duration: 6 months on W2 contract
 
Temp to perm: Yes based on performance and openings
100% Onsite - looking for local candidates
Shift Schedule: Monday – Friday, 8A – 5P. Should be flexible to work other shifts
 
Job Description
 
Core Essential Skills:
 
1. 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.
2. Minimum Master’s degree
 
 
POSITION SUMMARY
 
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.
 
ESSENTIAL AREAS OF RESPONSIBILITY
 
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).
 
POSITION REQUIREMENTS
 
Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.
 
Education/Certification/Experience:
 
  • 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
 
Skills/Knowledge/Abilities:
 
  • 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.
 
Contact: 
Sharath Babu: sharath.b@sunrisesys.com | (732) 395-4575 | URL: www.sunrisesys.com

About the Company

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Sunrise Systems Inc

Sunrise Systems was founded in 1990 with a clear vision to deliver world-class staffing service solutions in all labor categories, including IT consulting and solutions; all with the commitment to provide service that exceeds expectations and become the most trusted name in the industry. More than two and a half decades later, we pride ourselves on being at the forefront of the staffing industry. Combining our deep industry expertise, insights, and global resources, we have partnered with our clients to connect them with top professionals across several different industries.

We provide cost-effective Managed Staffing Solutions, Information Technology and Information Technology Consulting Services to several Fortune 500 companies and U.S. Government agencies. We provide our clients with flexible engagement models and customized products that are budget and time specific. Understanding the challenges that every business faces, we offer our services either on-site at the clients' site or from one of our globally distributed technology centers. Our onshore and offshore development capabilities ensure that we excel at meeting customer requirements every single time.

Our collective business experience spans over two and a half decades and ranges from:

  • Business, management, and technical fields
  • Information technology consulting and software solutions.
  • Providing strategic support for the development and long-term growth of new business ventures across several industries including but not limited to; accounting, banking, finance, and recruitment.
  • Motivating technology staff and establishing partnerships with Fortune 500 companies

Sunrise Systems has a vast range of competence in:

  • Design, development, and support of cloud-based solutions from simple to highly complexed
  • Database administration of multi-platform applications, complex databases, and web-based environments that include all aspects of installation, planning, maintenance, and monitoring.
  • Data processing and data migration
  • Application re-engineering and platform migration
  • Working with the Information Systems and end-user communities at all levels to resolve issues and establish consensus.
COMPANY SIZE
100 to 499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
1990
WEBSITE
http://www.sunrisesys.com/