LYNNE C.

MCCAFFERTY
3699 Stoughton Road
Collegeville, PA 19426
610-831-8089
lcmccafferty@msn.com

SUMMARY
Project Leader/Supervisor with demonstrated experience in the pharmaceutical cli
nical and commercial manufacturing environments. Served as liaison between all l
evels of operations to accomplish company's goals. Expertise in providing hands-
on leadership in various clinical data, manufacturing, clinical packaging, suppl
y chain, distribution, and government regulated projects. Recognized for organiz
ing resources to accomplish business objectives and being results-oriented. Work
ed effectively with employees at all levels of management to develop, implement,
coordinate, and strategically meet planned target dates. Areas of expertise inc
lude:
aStrategic Planning aProject Management
aResource Planning aStatistical Analysis
aSupervisory Management aInventory Management
aTeam Leadership aProcess Improvement
aGMP & FDA Requirements
COMPUTER SKILLS:
aSAP aMicrosoft Project aMRPII & III
aJDEdwards aMicrosoft Office Suite
CERTIFICATIONS:
a Microsoft Project, New Horizon, King of Prussia, PA - 2003
a Project Management, Pennsylvania State University, Great
Valley, PA - 2002
PROFESSIONAL EXPERIENCE:
NewAge Sys, Inc. Clinical Contract Division, Princeton, NJ
Clinical Supplies Label Room Associate Merck & Co., Inc
March 2008- March 2009
Read, comprehended, and translated clinical protocols /packaging specifications
into clinical label generation software. Designed clinical supplies trial labels
for primary, secondary, and auxiliary packaging applications. Interpreted rando
mization schemes, inputted into label software system, and utilized software to
verify correct labels are produced according to cGMPs. Adhered to all department
al SOP and GMP standards of quality, safety, and housekeeping.
Primary Care Giver Nov. 2006 a" Dec. 2007
Cared for an ill family member.
CARDINAL HEALTH, Philadelphia, PA
Clinical Packaging Supervisor, 2nd Shift May 2004 a" Oct. 2006
Directly responsible for providing supervisory leadership and direction for assi
gned union employees to complete clinical client work order(s) and to ensure max
imum production and highest quality of finished goods for the clients. Assigns s
pecific tasks, both routine and exceptional, to ensure the most effective and ef
ficient use of union employees during the execution of the clinical work order.
Ensures that tools and materials essential for the performance of the work are r
eadily available, cleaned, and QA approved for use. Review clinical batch record
s for completeness and accuracy during the execution of the clinical protocol. P
erform required JD Edwards transactions for labor, equipment, and components for
 each work order. Identifies potential improvements to the operation or product
under his/her control. Provides training and guidance to union employees

WYETH PHARMACEUTICAL LABORATORIES, West Chester, PA 1978 - 2002

Master Scheduler Oct. 1998 - July 2002
Responsible for the following:
aProduct Scheduling
Developed, planned, implemented, and coordinated the operation schedules for raw
materials, bulk, dosage, and packaging of sterile parenteral drug products. Dev
eloped and maintained computer generated reports to reflect the weekly and end o
f the month status for the parenteral sterile manufacturing units. Developed and
published a weekly production schedule for the manufacturing and packaging of t
he parenteral sterile drug products.
aReduced the manufacturing cycle time by 30% in a 3-
month period.
aMaintained optimal inventory levels at an average
of 98% over a 2-year period.
aInitiated, implement, coordinated, and maintained
data information to reflect the labor and equipment
hours needed to optimize manufacturing efficiency.
aCommitment Coordination
aRestructured the audit commitment process and
successfully achieved 100% completion rate.
a Led and participated in investigations of
Manufacturing Investigation Reports (MIRs) or
Manufacturing Variance Reports (MVRs)
a Initiated, composed, and finalized the MIRs or MVRs
to reflect any manufacturing deviation from the
approved SOPs.
a Developed and implemented the SOPs to prevent
reoccurrence of deviation.
Packaging Supervision
a Maintained a 100% completion of the weekly and
monthly production schedule for a 2-year period.
a Reviewed packaging batch records to ensure batch
documentation was accurate and GMP compliant
Warehouse Supervision
aWithin 2 months successfully revised inconsistent
warehouse SOPs to be compliant with FDA
requirements and corporate policies.
Manufacturing Annual Product Review (APR) Coordination
a Within 1 month revised and standardized the
electronic APR report and procedure for all
products.
Release Coordinator/ Packaging Supervisor June 1997 - Oct. 1998
Liaison between manufacturing and quality assurance to coordinate the release of
raw materials, sterile bulk formulas, sterile filled injectable drug products,
and packed products to meet the monthly Finished Stock Requirements Department (
FSRD) inventory requirements. Reviewed packaging batch records to ensure adheren
ce to GMPs and SOPs. Initiated, composed, and finalized MIRs and/or MVRs to refl
ect any deviation from approved SOPs. Supervised hourly work force.
aMaintained 98% of plant packaged product released
to finish stock.
aSupervised Penicillin Packaging to maintained 99%
of penicillin product released to finish stock.
aExecuted and coordinated various Technical Service
projects related to improve the parenteral
formulation process and to meet the FDA validation
 requirements.
Additional Experience:
Sterile Formulation/Label Preparation Supervisor
Supervisor Raw\Bulk Materials
Clinical Data Assistant
EDUCATION:
BS, Biology Kutztown University, Kutztown, PA