Compliance Specialist
Business Title:
101848 Compliance Specialist Location:
Marietta, PA 17547 Job Type:
Contract (9 M) Job
Responsibilities:
This position will perform deviation (unplanned events) investigations, identify root causes through root cause analysis (RCA), and determine CAPAs.
Investigate manufacture deviations (unplanned events).
Perform root cause analysis, using RCA tools.
Determine robust corrective actions and/or commitments.
Write deviations in SAP and prepare clear, concise reports from the outcome of investigations.
Interact and coordinate with appropriate personnel including manufacturing, QA/QC, regulatory, technical services, etc.
For RCA, review records to include batch documentation, training records, calibration records, standard operating procedures, regulatory policies, testing and manufacturing specifications, validation documents, and other technical documents.
Communicate immediately with QA and Operations management for all manufacturing discrepancies that impact product quality or safety.
Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, THE CLIENT standard operating & safety procedures, and industry practice and Industrial Excellence initiatives.
Skills & Experience Required:
Bachelor's degree in a relevant field Minimum of 2 years of demonstrated professional experience investigating manufacturing deviations, either in a QA, compliance, or manufacturing role in the pharmaceutical industry or equivalent, preferably in aseptic processes/areas.
Proficient in applying RCA for deviation investigations and deviation writing.
In-depth knowledge of root cause analysis methodologies, through training and practice.
SAP skills are a plus.
Knowledge of GMP's, NIH Guidelines, FDA, and other regulatory agency requirements sufficient to apply to quality operations and compliance.
Recommended Skills Calibration Operations Management Pharmaceuticals Quality Management Research Root Cause Analysis Estimated Salary: $20 to $28 per hour based on qualifications.
101848 Compliance Specialist Location:
Marietta, PA 17547 Job Type:
Contract (9 M) Job
Responsibilities:
This position will perform deviation (unplanned events) investigations, identify root causes through root cause analysis (RCA), and determine CAPAs.
Investigate manufacture deviations (unplanned events).
Perform root cause analysis, using RCA tools.
Determine robust corrective actions and/or commitments.
Write deviations in SAP and prepare clear, concise reports from the outcome of investigations.
Interact and coordinate with appropriate personnel including manufacturing, QA/QC, regulatory, technical services, etc.
For RCA, review records to include batch documentation, training records, calibration records, standard operating procedures, regulatory policies, testing and manufacturing specifications, validation documents, and other technical documents.
Communicate immediately with QA and Operations management for all manufacturing discrepancies that impact product quality or safety.
Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, THE CLIENT standard operating & safety procedures, and industry practice and Industrial Excellence initiatives.
Skills & Experience Required:
Bachelor's degree in a relevant field Minimum of 2 years of demonstrated professional experience investigating manufacturing deviations, either in a QA, compliance, or manufacturing role in the pharmaceutical industry or equivalent, preferably in aseptic processes/areas.
Proficient in applying RCA for deviation investigations and deviation writing.
In-depth knowledge of root cause analysis methodologies, through training and practice.
SAP skills are a plus.
Knowledge of GMP's, NIH Guidelines, FDA, and other regulatory agency requirements sufficient to apply to quality operations and compliance.
Recommended Skills Calibration Operations Management Pharmaceuticals Quality Management Research Root Cause Analysis Estimated Salary: $20 to $28 per hour based on qualifications.
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