Experienced Quality Control / Quality Assurance Worker – Hillside

NICOLE FENIAK           1015 Prospect St 2^nd Fl                                                                      (908) 965 – 3434 Home

• Support of the Microbiology groups across campus as follows:
• Review of all SOPs,  Protocols, Studies, Summary Reports, Validations and Trend Reports
• Review and Approval of Alert and Action Excursions
• Review of Non- Conformance Events (NCE’s) via TrackWise Database System
• Review and Approval of Corrective and Preventative Actions (CAPA’s) via TrackWise Database System
• Scribe and/or Runner during Micro Laboratory Audits/Inspections
• Attendance of weekly Cross Functional NCE Meetings and for Cross Functional Microbiological Investigation
• Observation of Microbiology processes as needed
• Attend off-site vendor audits as needed

• Consent Decree work experience
• Prepare Protocol and Summary Reports for Marketed and Clinical Manufacturing SOP’s per GMP work plan
• Review of environmental monitoring sites based on Statistical Analysis of historical data
• Participate in updates, revisions, and implementation of Monitoring programs, protocols, SOP’s per World Wide Level II Standards, GMP’s, Work Plan, Lachman, and FDA commitments
• Prepare Weekly Laboratory Investigation Reports (LIR’s), Notice of Events (NOE’s) and Microbiological Environmental Notifications (MEN’s) in TrackWise and paper system Metric for Metrics Meeting
• Chair Weekly Metric Meeting
• Prepare Monthly Environmental Metric for Directors Site Quality Council Meeting
• Assembly of NOE/MEN packages for Manager consisting of reviewed data, LIR(s), related NOE/MEN, related data sheet(s) and microbial identification(s)
• Review of identified microorganisms for NOE/MEN packages
• Assisted in the review of PLIR’s, LIRs and NOE’s
• Provide technical support for the implementation of the Microbiology Environmental LIMS system
• Liaison for the Lachman Audit in Schering Plough Manati, PR
• Liaison for the execution of the Surface Methods with World Wide Technical Services Microbiology
• Prepare documents for the Annual Reports
• Train the Trainer Program, Technical Writing Course, and Kepner Tregeo Problem Solving Workshop

• Temporary Acting Supervisor during Supervisors absences
• Provide group trainings for updated/revised/new procedures and protocols
• Provided Analyst trainings on aseptic technique, environmental monitoring equipment, methods and sites, biological indicator and endotoxin indicator certification and processing
• Writing Preliminary Investigation Reports (PLIR’s), and LIR’s
• Review of environmental monitoring paperwork and MEN
• Review of endotoxin indicator certification and testing
• Review of  biological indicator certification and processing
• Review of equipment charts and autoclave charts.
• Scheduling quarterly training sessions for manufacturing, validation, clinical and maintenance personnel
• Preparation of necessary documentation and equipment for training sessions
• Provide training sessions
• Preparing Monthly Meeting Minutes & Packages
• Chair Monthly Manufacturing and Clinical Microbiology Meetings
• Collecting Bi-Monthly Component Samples for Aerosols and Nasonex
• Liaison for microbial issues during manufacturing for Schering Plough Florida at the University of Iowa

• Qualified and trained for sterile area manufacturing
• Endotoxin indicator certification and testing
• Biological indicator certification and processing
• Preparing and running endotoxoin indicators for oven validations
• Writing validation protocols and performing validations as needed: including writing summary reports
• Conducting Water Site Investigations and issuing Pre-Microbiology Environmental Notifications (PRE-MEN’s) as needed
• Writing MEN’s
• Writing/Revising/Updating SOPs and Protocols
• Preparing LAL supplies and Running Depyrogentaion Cycles
• Autoclaving of media and monitoring supplies

• Environmental Monitoring which includes STA, RCS, SAS, GAP, Swabs, PC, DP, Contact Plate samples,
• Sampling of Water Sites
• Analysis Water For Injection (WFI), Purified Water (PW), Distilled Purified Water (DPW) and City Water
• LAL Analysis of WFI, PW and DPW
• Bioburden Analysis which includes receiving, collecting and analysis of component bioburdens
• Receivial and growth promotion of media

• Responsible for laboratory testing and evaluating raw materials and finished products
• Quality Assurance Testing of Media, Organisms, Water, Air and Drugs for Injection
• Analysis of Purified Water
• Preparation of Microbiological Media
• Cryopreservation and Subculturing of Organisms
• Shake flask Fermentation
• Inventory of Laboratory Supplies
• Method Development and Validation
• Writing and Reviewing Microbiological SOP’s
• Daily Cleaning and Laboratory Maintenance

• Microsoft Office
• Excel
• Power Point
• Access
• Outlook

• William Paterson University

• Kean College of New Jersey

• Available upon request