To Discuss more about this job opportunity, please reach out to Anwesha Mohapatra (LinkedIn URL -Anwesha Mohapatra - Collabera | LinkedIn), email your updated resume at Email - anwesha.mohapatra@collabera.com. Thank you!

Pay Range: $30/hr to $35/hr

Job Title: MS&T Specialist I

Location: Davie, FL 33314

Work Type: Onsite

Contract Duration: 03 months with possible extension or conversion

Job Summary:

• The MS&T Specialist I will support cGMP investigations within pharmaceutical oral solid dose manufacturing operations.
• This role will lead complex investigations, root cause analysis, product impact assessments, and CAPA activities across manufacturing, engineering, quality control, and related support functions.
• The position requires strong technical judgment, analytical problem solving, and the ability to evaluate manufacturing, equipment, laboratory, and process data.
• The successful candidate will work closely with cross functional teams to identify sustainable solutions and support compliant commercial manufacturing operations.
• The role also contributes to continuous improvement, process validation, technical troubleshooting, and inspection readiness activities.

Key Responsibilities:

• Lead and coordinate cGMP investigations involving deviations, nonconformances, atypical events, and complex manufacturing operations.
• Coordinate event triage, containment, escalation, and immediate actions while supporting product disposition activities with Operations, Engineering, Quality Control, and Quality Assurance.
• Collect, organize, and analyze batch records, equipment records, maintenance information, laboratory results, process data, calibration records, environmental monitoring data, and other relevant evidence.
• Conduct structured root cause analysis using methods such as 5 Why, fishbone analysis, and fault tree analysis.
• Develop technically sound investigation conclusions, product impact assessments, corrective actions, preventive actions, and effectiveness checks.
• Prepare clear and compliant investigation and CAPA documentation using Good Documentation Practices.
• Analyze and trend manufacturing, equipment, and laboratory data to identify recurring issues and support risk based decisions.
• Collaborate with Manufacturing, Quality, Engineering, Regulatory, and other cross functional teams to resolve technical issues and prevent recurrence.
• Support continuous improvement, audit readiness, inspection readiness, and implementation of sustainable remediation activities.

Required Qualifications:

• Master’s or PhD degree in Science, Engineering, or another relevant scientific discipline.
• Strong experience in pharmaceutical manufacturing, technical services, investigations, or a related GMP environment.
• Experience leading or supporting deviation investigations, root cause analysis, CAPA development, and technical problem solving.
• Strong understanding of cGMP requirements, pharmaceutical quality systems, data integrity, and regulatory expectations.
• Experience with technical writing and preparation of investigation, deviation, CAPA, and product impact documentation.
• Strong analytical and critical thinking skills with the ability to interpret manufacturing, equipment, and laboratory data.
• Excellent written and verbal communication skills with the ability to collaborate effectively across multiple functions.

Preferred Qualifications:

• Direct experience with oral solid dose pharmaceutical manufacturing.
• Experience with blending, granulation, compression, coating, encapsulation, or related OSD processes.
• Experience with process validation, technical transfers, continuous improvement, automation, or digital manufacturing tools.
• Experience with electronic quality systems, manufacturing execution systems, laboratory information management systems, historian systems, or trending platforms.
• Operational Excellence experience or Green Belt or Black Belt certification.
• Experience supporting commercial manufacturing operations and inspection readiness.

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)