1. Sal Z. Jaffri
1959 51st Street▪Brooklyn, NY 11204▪(347) 276-8538▪ sjaffri01@gmail.com
Highly Versatile in Quality Control Testing and Assessment
Experience/Objective: Looking to expand experience in all levels of microbiological testing. Possess
quality control experience in cGMP and FDA processes in both microbiological quality control as well as
other pharmaceutical procedures within QA regulatory affairs. Seven years experience within the field of
pharmaceutics, possessing exceptional communication skills with the ability to work in both a team
setting as well as in an independent environment.
Pharmaceutics International Inc. (Pii), Hunt Valley MD Sept 2008-Present
Microbiologist (Quality Control)
 Performed Bio burden water testing, coliform water testing, specified organism testing and nitrate
testing
 Performed media preparation
 Responsible for environmental monitoring of manufacturing facilities via Settle Plate Method and
Air Sample Method
 Created environmental monitoring trend data analysis
 Responsible for water sampling throughout manufacturing facility
 In charge of disposal of biological hazardous waste materials
 Organized and performed validation of laboratory equipment to bring efficiency to work place
 Created a successfuldatabase system for scheduling monthly environmental monitoring within
non-sterile manufacturing facilities.
 Authored standard operating procedures (SOPs) and test methods
 Assessed and implemented Corrective Action for Out-of-Specification results
 Supported successfulquality system to ensure cGMP in accordance with FDA regulations
 Performed anti-fungal, anti-bacterial fogging of microbiology lab
 In charge of tracking controlled substance inventory, record and data keeping
 Trained other incoming microbiologists on lab procedures
 Assisted on other special projects in addition to duties assigned
Quality Assurance Inspector (Quality Control)
 Performed procedures in accordance with cGMP and FDA regulations
 Familiarity with PPE (PersonalProtective Equipment)
 Responsible for line clearance approval
 Performed extraction of, and submitting of blend uniformity samples
 Responsible for all quality in-process checks during manufacturing process
 Actively participated in batch record review
 In charge of QA retain/controlled product database organization
 Actively assisted on other special projects in addition to duties assigned

2. Quality Assurance Investigator (Quality Control)
 In charge of log and maintenance of data base for all incidents, allegations of abuse and notable
occurrences.
 Completed any follow up requests and investigations of notable occurrences.
 Assisted with program audits and satisfaction surveys.
 Serious and Non Serious Reportable Incidents.
 Assisted with preparation and follow up for Special Review Committee.
 Presented training; recommendations for revisions/method of presentation.
 Assured that all notifications have been made within time frames required by regulations for
Incidents and notable occurrences.
 Assisted in updating and copying QA forms, training materials, policies and procedures.
 Assisted with program audits and surveys as assigned.
 Communicated with Coordinator on a daily basis regarding any findings such as consumer care
issues or systemic issues.
 Assisted the Quality Assurance Coordinator with additional assignments as needed.
Aseptic Manufacturing Technician
 Performing procedures in accordance with cGMP and FDA regulations
 Performed cleaning and re-sanitization of work area for all equipment
 Arranged sterilization and maintenance of all clean rooms, processing areas and equipment
 Operated product filter integrity testing
 Vial washing machine operation
 Performed autoclave operation and sterilization of equipment
 Responsible for preparation of tubing and other equipment for manufacturing processes
 Performed anti-fungal, anti-bacterial fogging for non-aseptic manufacturing area
Internal Auditor
 Researching and assessing how well risk management processes are working and recording the
results.
 Provided advice/guidance to managers and staff at all levels
 Performed risk assessments on key business activities and using this information to guide what to
cover in audits.
 Performed risk assessment on employee training system
 Anticipating emerging issues through research and interviews and deciding how best to deal with
them.
 Prepared reports to highlight issues and problems and distributing the reports managers and
relevant personnel.
 Developed a Training Manager System for Quality Assurance personnelfor storage and
maintenance of training records.
Education
Windsor University School ofMedicine: St. Christopher’s (St. Kitts)
August 2003- October 2005
Vanderbilt University: Nashville,TN
BS Cognitive Studies (Psychology) 2002
Concentration: Pre-MedicalStudies
Key Skills
Computers: Microsoft Office Suite (Word, Excel, PowerPoint)