1. KATHLEEN SLEISTER
509 Howard Road, Cherry Hill, NJ 08034 ▪ 856 910-8489 ▪ bobellib@gmail.com
QUALITY ASSURANCE ▪ MEDICAL PACKAGING ▪ PHARMACEUTICALS
Experience in FDA regulated manufacturing and quality operations
Recently trained as a Green Belt in Lean Six Sigma
● QA Documentation / Change Control ● FDA Compliance & Audit Experience
● Customer Complaint Investigation & Response ● Procedures, SOP’s & Staff Training
● Clinical & Open Label Packaging ● Root Cause Analysis & CAPA
LABORATORY METHODS & INSTRUMENTATION
USP, AA-AE and Plasma Emission Spectroscopy; Microbiology LAL & Membrane Filtration), wet chemistry,
Instron tensile tester, package tester (creep and burst tests), Gurley Densometer, Polarimeter
PROFESSIONAL EXPERIENCE
Complaint Specialist, Lannett Company, Inc., Philadelphia, PA 2015 to Present
Supplier of generic pharmaceutical products
Conduct product complaint investigations in compliance with 21CFR Part 211. Responsible for the
assessment and reporting of Field Alert Reports within required timeframe. Coordinate Postmarketing
Surveillance of Drug Adverse Effects. Submit periodic and 15-Day Alert Individual Case Safety Reports
electronically through the FDA Safety Reporting Portal. Provide assistance for the investigation and reporting
of Manufacturing Investigation Reports and Deviation Reports (planned and unplanned).
➢ Responsibilities expanded in the first six months to include submission of field alert reports to the FDA
➢ Reduced Complaint Investigations time by 20%
➢ Standardized the Procedures for Product Complaints, Adverse Events, Field Alert Reports, and
Voluntary Recalls
QA Supervisor, Bemis Healthcare Packaging, Philadelphia, PA 2014 to 2015
Quality Engineer, Bemis Healthcare Packaging, Philadelphia, PA 2007 to 2014
Global supplier of medical drug/device, and pharmaceutical packaging
Conduct internal audits for compliance to ISO 13485 and GMPs. Conduct root cause (5Y, fishbone diagram)
investigations and implement Corrective & Preventive Action (CAPA) for customer complaints, SAP key user
for Quality, Develop Failure Mode Effect Analysis (FMEA) and Process Control Plans, Conduct Gage R&R
studies, Conduct First Article Analysis and Product Validation of Printed and Converted Product. Develop
Standard Operating Procedures (SOP’s) and conduct staff training.
➢ Assign (CAPA) and review responses to internal/ external audits.
➢ Compile and deliver weekly/monthly metrics in Excel spreadsheets to upper management.
➢ Maintain internal notification database, audit blocked material inventory, and audit batch records.
➢ Conduct Material Review Board (MRB) and product disposition activities.
➢ Conduct Documentation Control activities by issuing SOPs in accordance with change control
procedures.
QA Engineer, NexMed (U.S.A.), Inc., Robbinsville, NJ 2005 to 2006
Start-up pharmaceutical/proprietary drug delivery development
Provided QA support to R&D / Product Development to scale-up manufacturing site to package clinical trial
materials and prepare for FDA pre-approval inspection. Participated in collaborative writing of quality and
manufacturing work instructions, procedures, and specifications. Developed PM, calibration and standardized
equipment ID nomenclature for analytical, QC, and manufacturing departments.
➢ Rehired as QA representative during external secondary packaging operations to verify
2. Kathleen Sleister – Page 2
compliance with specifications.
➢ Reduced cost by bringing secondary packaging and labeling in-house: implemented labeling,
distribution, and reconciliation procedures; trained QC and packaging personnel; performed and
supervised labeling operations.
Process Compliance Engineer, Fresenius Medical Care North America, Delran, NJ 2002 to 2004
Major provider of kidney dialysis services and renal care products
Provided QA expertise, oversight, and coordinate the PM and Calibration Programs. Disposition and
organization of equipment service records. Developed SOPs and conducted training on equipment operation.
Issued, reviewed, and approved validation protocols and facility change control documents.
➢ Rehired by company to resolve FDA compliance issues; successfully updated PM/Calibration
Procedures, resolved PM backlog, and completed three process validations to meet a 4-month
commitment to FDA.
➢ Developed and coordinate a cross-departmental sanitization team - validated equipment and water
system sanitization procedures: reduced downtime by two days - expanded scope and frequency to
meet quality requirements.
QA Engineer, NexMed (U.S.A.), Inc., Robbinsville, NJ 2001 to 2002
Start-up pharmaceutical/proprietary drug delivery development
Conducted technical and QA audits of batch records, conduct internal GMP audits, conduct Supplier audits,
production logs, QC, and stability data - responsible for identifying discrepancies, evaluating product impact,
recommending and performing CAPA. Approved clinical trials for distribution.
➢ Assisted with the validation and commissioning of new manufacturing facility: reviewed protocols,
assisted with cleaning and equipment validation, equipment FAT, assessed and remediated computer
system to comply with CFR 21 Part 11, coordinated IQ, OQ, PQ on stability and storage chambers.
➢ Trained laboratory personnel on GLP & cGMP to increase quality and reduce deviations and OOS
events.
QC/QA Compliance, Fresenius Medical Care North America, Delran, NJ 1989 to 2001
Provider of dialysis care services, education & support for Chronic Kidney Disease (CKD)
Promoted with increasing responsibility within the Quality Organization. Effectively performed QC / QA
functions, including internal GMP audits, to provide support to manufacturing and improve quality operations.
QA Supervisor 1996 - 2001
Quality Engineer 1994 -1996
QC Supervisor-Chemistry 1989 -1994
➢ Performed chemistry and microbiological analysis on purified water, chemical components, and
hemodialysis concentrate product / conducted OOS investigations.
➢ Improved label control procedures: standardized, inspection, approval, and production issuance
procedures to reduce errors and prevent mix-ups / supplied labeling to three manufacturing sites.
➢ Supervised QC Chemists and Inspectors, and QA Documentation Administrators / reported
departmental metrics to upper management.
➢ Performed calibrations on laboratory and process equipment including analytical and process scales,
inline checkweighers, Eppendorf pipettes, hydrometers, thermometers and temperature recorders,
magnehelic gages, torque wrenches, label counting and inspection tables.
EDUCATION
B.A., Biology, Magna Cum Laude, Rowan University (Glassboro State College), Glassboro, NJ
3. Kathleen Sleister – Page 3
COMPUTER SKILLS
Microsoft Office (Word, Excel, PowerPoint, Access, Visio, Outlook), Minitab Statistical Program, SAP Quality,
Word Perfect, Paradox, Blue Mountain Calibration Manager, Domino.Doc, Liberty Labs Train Track, QUMAS
Quality and Regulatory Compliance Software
TRAINING
Lean Six Sigma Green Belt, Bemis Healthcare Packaging, Bemis Black Belt
Quality Inspection Tools ES131; c=0 sampling plan, ASQ, Ray Lotfi
Understanding and Applying Failure Mode Effects Analysis FMEA, ASQ, Ray Lotfi
Supervisor CDS Use and Abuse Recognition, Baltimore County Fire & Medical Training Inc,
Understanding FDA's Medical Device Quality System Regulation, Oriel Stat a Matrix
Internal Auditing Training for ISO 13485, Oriel Stat a Matrix
Adverse Event and Product Quality Complaint Awareness, Johnson and Johnson eUniversity
Statistics with Minitab Course, Bill Rodenbaugh, Six Sigma Master Black Belt
Root Cause Analysis, Bill Rodenbaugh Six Sigma Master Black Belt
ISO 13485:2003 Internal Auditor Course, BES Consulting
Introduction to Internal Auditing, Paton Professional
