To Discuss more about this job opportunity, please reach out to Deepak Arya (LinkedIn URL - www.linkedin.com/in/deepak-arya-8a79aa22a/), email your updated resume at Email - deepak.arya@collabera.com. Thank you!

Pay Range: $30 to $35 per hour.

Client Industry: Pharmaceutical

Duration: 3 Months Contract (Temp to Perm based on performance and available openings)

Job Summary:

The GMP Investigator will lead and perform cGMP investigations supporting pharmaceutical Oral Solid Dose manufacturing operations. The role focuses on investigating deviations, nonconformances, atypical events, and complex manufacturing or equipment issues. This position requires strong technical judgment, root cause analysis, data evaluation, and technical writing capabilities. The successful candidate will collaborate closely with Manufacturing, Quality, Engineering, QC, and other cross functional teams to identify sustainable solutions and maintain compliant pharmaceutical operations.

Key Responsibilities:

• Lead and co author cGMP investigations involving deviations, nonconformances, atypical events, and complex manufacturing operations.
• Coordinate event triage, containment, escalation, and immediate actions with Manufacturing, Engineering, Quality, and QC teams.
• Collect, organize, and analyze manufacturing, engineering, equipment, and laboratory data to establish event sequences and contributing factors.
• Facilitate root cause analysis using structured investigation methodologies and document technically sound conclusions.
• Evaluate product impact and support batch disposition activities in collaboration with cross functional teams.
• Develop, document, and track CAPAs, corrective actions, preventive actions, due dates, and effectiveness checks.
• Prepare clear and complete investigation reports, product impact assessments, and CAPA documentation in accordance with GMP and Good Documentation Practices.
• Analyze and trend manufacturing, equipment, and laboratory data to support risk based decisions and continuous improvement.
• Use electronic quality systems and manufacturing data systems to support investigations, trending, and effectiveness monitoring.
• Collaborate proactively across Manufacturing, Quality, Engineering, QC, and Regulatory functions to resolve technical issues.
• Support audit and inspection readiness by preparing investigation evidence packages and responses.

Required Qualifications:

• Master’s degree or PhD in Science, Engineering, or a related technical discipline.
• Experience supporting investigations within pharmaceutical manufacturing, engineering, QC laboratories, or another regulated GMP environment.
• Experience leading or contributing to complex deviation, nonconformance, atypical event, or GMP investigations.
• Strong knowledge of cGMP requirements, pharmaceutical quality systems, data integrity, and Good Documentation Practices.
• Experience with root cause analysis methodologies such as 5 Why, Fishbone, or Fault Tree Analysis.
• Experience developing and tracking CAPAs and effectiveness checks.
• Strong technical writing, analytical, problem solving, communication, and cross functional collaboration skills.
• Ability to work 100% onsite in Davie, Florida and flexibility to support other shifts when required.

Preferred Qualifications:

• Direct experience in pharmaceutical Oral Solid Dose manufacturing.
• Experience with blending, granulation, compression, coating, or encapsulation operations.
• Experience with process validation, technical transfers, continuous improvement, or manufacturing automation.
• OPEX, Lean, Six Sigma, Green Belt, or Black Belt experience.
• Experience with electronic quality systems, MES, SCADA, LIMS, historian systems, dashboards, or other manufacturing data tools.
• Experience supporting commercial pharmaceutical manufacturing operations.

Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)