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Compliance Specialist I Compliance Specialist I
Ref No.: 18-06870
Location: Ridgefield, New Jersey
Support the Quality Assurance Department in protecting the safety, quality and efficacy of company products ensuring compliance with cGMP.
Independently perform Quality Assurance walkthroughs of classified manufacturing areas to observe and evaluate production activities, aseptic processes and the proper execution of Batch Production steps. In a timely manner identify any deficiencies and provide proper notification to area management. Prepare Quality Assurance walkthrough summary reports detailing the walkthrough findings and identify any follow up items that require escalation to Area Management.
Perform trending of all environmental monitoring and process utility data. Review the trends in real time and escalate any issues to Senior Management. Calculate Contamination Recovery Rates (CRRs) for all Graded Manufacturing areas and personnel and recommend CAPAs for continual improvement. Prepare and present quarterly environmental and process utility trend report.
Lead an Environmental Action Committee (EAC) and routine EAC meetings. In conjunction with the EAC, review environmental monitoring and process utility data and trend reports, CAPA remediation for effectiveness, project plans, walkthrough findings and other issues related to environmental control systems. Escalate critical issue and adverse trends to Senior Management and recommend CAPAs.
Lead the Aseptic Process Simulation (Media Fill) program. Ensure the program continues to comply with corporate and regulatory requirements. Maintain the aseptic processing schedule and ensure execution to plan. Author all final summary reports for Aseptic Process Simulations. Maintain and manage a team for media fill observations. Escalate finding to Management as required.
Lead the Alarm Reconciliation Program ensuring all facility Critical alarms generated are accounted for and proper root cause, corrective action and event assessment is complete and accurate. Maintain alarm logs and present data and findings at monthly EAC meetings.
Update Quality Assurance standard operating procedures. Perform Gap assessments of corporate standards and guidance documents. Participate in Container Closure Integrity Test (CCIT), Low Endotoxin Recovery (LER) and Monocyte Activation Test (MAT) programs. Provide Quality Assurance and Microbiological knowledge to facility improvement process or projects as required.

Microbiology knowledge
Aseptic Technique and Aseptic Gowning Experience
Proven, strong technical writing skills
Demonstrated ability to communicate clearly and effectively both orally and in writing
Demonstrated time management, attention to detail, organization skills, teamwork and collaboration.
Demonstrated ability to interact and present information to upper level management