High School Customer

KELLY SPANG

*** ****** ***** **, ***********, NC 28115 440-***-**** ********.**@*****.***

Summary

An accomplished leader on continuous improvement and compliance in an FDA/EMA

regulated environment. Specialized in aseptic processing, contamination control,

testing, CAPA, and continuous improvement. During my career, I have met aggressive

timelines to support regulatory expectations, conducted high level investigations, and

hosted and supported inspections, including FDA and EMA. Proven ability to drive

continuous improvement through coaching/development of the staff on the floor. I will

take any opportunity to teach and learn. True leadership comes by actively listening and

supporting your staff.

Core Skills

Skills

Writing reports for failure investigations and process deviations (PTi international

certification) and conducting effective investigations (Ben Venue Labs).

Introduction to lean six sigma (Kent State University).

Six Sigma Green Belt Certification (TRI-C, scheduled to complete 7/23/2014)

Comprehensive industrial course in the preparation of parenteral products (UT Health Science

Center).

Project Management (TRI C, certification pending exam)

Microsoft Access, PowerPoint, Word, Outlook, Excel, Project

Trackwise

LIMs

CAPA/Effectiveness reviews

Training

Soft skills

Building Bridges Not Barriers (Ben Venue Labs).

Crucial Conversations (VitalSmarts).

Certified Coach (Ben Venue Labs).

Breaking the victim mentality.

Experience

04/2014- Supervisor, QC Microbiology, Kelly Services, Johnson and Johnson

08/2014

Subject Matter Expert (SME) for regulatory and customer audits.

Coordinate testing to ensure release metrics are met.

Coach Microbiologist to make quality decisions.

Approve paperwork and deviation/investigations.

Manage protocols for developmental testing and facility validation activities from generation

to final result.

Ensure lab was following lean principles.

Ensure Environmental Monitoring data is communicated to Operations and Quality

Represent Microbiology for Consent Decree (CD) disposition meetings.

Primary reviewer for environmental monitoring investigations

Report Quarterly Trend report.

07/2008- Supervisor, QC Microbiology, Ben Venue Laboratories

12/2013

Interview, hire and perform performance reviews on all employees. In addition, I assigned

individual and departmental goals in line with the company strategy.

Subject Matter Expert (SME) for regulatory and customer audits.

Coordinate testing to ensure release metrics are met.

Empower Microbiologists to shape their processes to ensure metrics are met and quality is

consistently improved.

Coach Microbiologist to make quality decisions.

Approve paperwork and deviation/investigations.

Manage protocols for developmental testing and facility validation activities from generation

to final result.

Ensure lab was following lean principles.

Develop staff on technical knowledge.

Keep lines of communication open for all internal and external customers.

05/2007- Compliance Coordinator, Ben Venue Laboratories

7/2008

Perform vendor audits of contract manufacturing facilities and contract testing laboratories.

Perform vendor audits of active pharmaceutical ingredients (APIs), excipient and primary

packaging materials.

Perform internal audits.

Host contract customer and regulatory audits.

Coordinate ready room activities during regulatory audits.

Create effective corrective and preventive action plans.

Communicate issues with upper management.

Provide project management and regulatory support to all departments.

03/2005- QA Investigation Specialist, Ben Venue Laboratories

5/2007

Investigate Out of Specification (OOS) results on final product endotoxin, sterility, and

particulate for root cause.

Investigate Out of Specification (OOS) results on in process and raw material bioburden and

endotoxin.

Page 2

Create effective CAPAs upon completion of the investigation. Track effectiveness checks.

Ensure Environmental Control’s CAPAs were completed before due dates.

Respond to customer and regulatory observations and assign CAPAs, when necessary.

Review testing and completeness.

Provide direction in absence of supervision.

Primary microbiological auditor for contract customer audits.

01/2002- Microbiologist, Ben Venue Laboratories

3/2005

Monitor sterile production suites for viable and non-viable particulates.

Identification of organisms using the Vitek identification system.

Bioburden, endotoxin (LAL), particulate testing and sterility testing on Water For Injection

(WFI) and drug products.

Validation of test methods.

Understanding the importance of following cGMPs when manufacturing quality products.

Following Standard Operating Procedures (SOPs) in a regulated environment.

Education

May 2001 Marine Biology, Roger Williams University

June 1997 High School Degree, Bay Village High School

Page 3

Contact this candidate