Job Description:
The Sr. Associate Compliance (Investigations, CCR, PQCs) provides scientific support in the
root cause analysis and closure of OOS investigations, OOT investigations and product quality
complaints; ensures compliance with Good Laboratory Practices (GLP), current Good Manufacturing
Practices (cGMP) and Quality Management System standards, compiles monthly Quality metrics for
internal and corporate review, and analyzes trends to implement corrective and preventive
actions to mitigate adverse trends.
 
Collaborate with multiple departments to ensure timely documentation, root cause analysis, and
QA closure of Stage II OOS investigations and OOT investigations.
Work directly on technical investigations relating to product quality complaints.
Provide verbal and written responses/resolutions to customers regarding Product Quality
Complaints or product inquiries.
Conducts Investigations of Site Incidents/Deviations and Product Quality Complaints in
TrackWise system and provides final review.
Ensures a robust deviation management program is executed to ensure effective root cause
analysis and corrective and preventative action identified and completed.
Reviews and approves Change controls, CAPA and Global CAPA and monitors the effectiveness of
CAPA.
Ensure adequate tools used during the investigations.
Participate in all manufacturing/Quality control related to the investigation.
Generate Summaries for the investigations; Trending of Site Incidents; Product Quality
Complaints; Out of Specifications; Out of Trends on monthly; Quarterly and annually basis.
Ensure effectiveness check of Corrective and Preventive actions.
Ensure adequate risk assessments are performed using tools like Failure Mode Effect Analysis.
Manage investigations related to complaints, planned, unplanned deviations, FAR, Quality alerts
and batch failures. Assists in ensuring FDA Readiness Plan for the facility. Provides support
for all regulatory audits, internal/external inspections,