Job Summary:

The Deviation Investigations Specialist will lead and perform cGMP investigations supporting pharmaceutical Oral Solid Dose manufacturing. This role will investigate complex manufacturing, equipment, and laboratory events, identify root causes, assess product impact, and develop effective Corrective and Preventive Actions. The position requires strong technical judgment, investigation experience, and cross-functional collaboration across Manufacturing, Quality, Engineering, and Laboratory teams.

Key Responsibilities:

• Lead or co-author cGMP investigations involving deviations, nonconformances, and atypical events within Oral Solid Dose manufacturing.
• Coordinate event triage, containment, escalation, and immediate actions while supporting product disposition decisions.
• Collect and analyze manufacturing, engineering, equipment, and laboratory data to establish event timelines and contributing factors.
• Facilitate root cause analysis using structured methodologies such as 5 Why, fishbone, and fault tree analysis.
• Assess product impact and document scientifically sound, compliant investigation conclusions.
• Develop, document, and track Corrective and Preventive Actions, including effectiveness checks and implementation activities.
• Prepare clear and complete investigation and CAPA documentation in accordance with Good Documentation Practices.
• Support investigation trending, continuous improvement, audit readiness, and regulatory inspection preparation.
• Collaborate effectively with Manufacturing, Quality, Engineering, Quality Control, and other cross-functional teams.
• Analyze process, equipment, and laboratory information to identify trends and recommend sustainable technical solutions.

Required Qualifications:

• Master’s or Ph.D. degree in a scientific or engineering discipline.
• Relevant experience supporting investigations within pharmaceutical manufacturing, Engineering, Quality Control, or related GMP environments.
• Strong knowledge of cGMP, pharmaceutical quality systems, data integrity, and Good Documentation Practices.
• Experience with deviation investigations, root cause analysis, and CAPA development.
• Strong technical writing and documentation skills, including investigation reports and product impact assessments.
• Strong analytical and problem-solving skills with the ability to evaluate manufacturing, equipment, and laboratory data.
• Excellent written and verbal communication skills with the ability to work effectively across multiple functions.
• Ability to work onsite in Davie, Florida, Monday through Friday, 8:00 AM to 5:00 PM, with flexibility to support other shifts when needed.

Preferred Qualifications:

• Experience in Oral Solid Dose pharmaceutical manufacturing, including blending, granulation, compression, coating, or encapsulation.
• Experience in a pharmaceutical manufacturing facility supporting commercial operations.
• Experience using electronic quality systems and manufacturing or laboratory data systems such as eQMS, MES, LIMS, and historian or trending tools.
• Experience with process validation, technical transfers, continuous improvement, automation, or digital manufacturing tools.
• Experience with Operational Excellence initiatives or Green Belt or Black Belt certification.
• Strong experience leading complex investigations and working across Manufacturing, Quality, Engineering, and Regulatory functions.

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 off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.

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

If interested, you can also share your resume at gagandeep.singh@collabera.com