Management Manager
Resume:
Tammy D Dissinger
Email: ********@*****.***
Phone:
Address: *** ******* ****
City: Ephrata
Province: Pennsylvania
Postal Code: 17522
Location: USA
End Jobseeker Information
Resume Information
Summary: My resume that highlights my ability/knowledge/expertise in all aspects of Laboratory Management in
Resume Categories: Biotech / Pharma
Resume:
Tammy D. Dissinger
129 Hemlock Road
Ephrata, PA, 17522
********@*****.***
Summary: Over 15 years of experience a GMP pharmaceutical industry; recent experience in a CD environment. Experience includes supervising and developing people and talent, technical supervision and management of the QC Analytical Laboratory Team according to all CFR regulations, cGMP/GLP, and EHS requirements, cross-functional technical support and collaboration across a multi-site network, technical writing and investigatory skills, analytical method development and transfer, cleaning validation, Marketed Product Stability, Computer Systems Validation, Process Validation, Equipment Cleaning Validation, Change Management / Change Control and Process Excellence.
Education: BS in Chemistry, May 1994, Millersville University
Functional Manager Program, April, 2005, Penn State
Professional Experience
McNeil, CPC, Lancaster: QC Team Leader, Analytical Lab (May 2007 – August 2012)
Supervise Analytical Laboratory, primarily responsible for meeting all customer needs in the Solids OTC Division; including data review and batch approval in LIMS, authoring and/or approving Laboratory Non-conformance Investigations, and overall lab operations according to all cGMP / GLP, CFR and EHS requirements. Concentrated efforts in analyst cross-training, and new technology implementation in order to increase lab capacity and maximize resources allowing for Lean improvements and collaborative support to other aspects of the business across the network. Responsible for the successful Empower2 Computer Systems Validation and implementation in order to harmonize chromatography data collection across the multi-site network and prepare for the upcoming SmartLab interface. As a Laboratory Systems Subject Matter Expert, responsible for assuring successful FDA, MHRA, ESH, MAARS, ISO and Central Quality Audits and maintaining continuous audit readiness within the laboratory. I
mplemented Laboratory Process Review Team (2007) to improve laboratory communications, level load analysts’ work and manage priorities. Additional focus in Operations Equipment Cleaning Validation, Process Validation, and Approval of Master Validation Plans for both.
McNeil, CPC, Lancaster: Stability Facilitator / Sr. Analytical Chemist (July 2002 – April 2007)
Supervise Analytical Laboratory, primarily responsible for the Marketed Product Stability and Finished Goods Retain Programs, Laboratory Non-conformance Investigations, and overall lab operations according to all cGMP / GLP, CFR and EHS requirements. Responsible for assuring appropriate Annual and Change Control required MPS initiation according to McNeil Policy and Regulatory requirements. Member of the Lancaster Change Control Committee.
McNeil, CPC, Lancaster: Analytical Chemist II (August 1999 – July 2002)
Responsible for Solids, Liquids, and Chemical Component analyses according to applicable Method Specifications, Compendia, and cGMP / GLP requirements in order to meet established release metrics, troubleshooting equipment and performing majority of annual instrument calibrations (HPLCs, GCs, AA, ICP). Responsible for overseeing laboratory in the absence of the Laboratory Facilitator, including data review, batch approval in LIMS, chemical component release in SAP. Provided mentoring for other analysts on troubleshooting various instrumentation and provided training to other analysts in order to support talent development and cross-training.
McNeil, CPC, Lancaster: Analytical Chemist I (June 1997 – August 1999)
Responsible for Solids, Liquids, and Chemical Component analyses according to applicable Method Specification, compendia, and cGMP / GLP requirements in order to meet established release metrics.
Kelly Scientific, Analytical Chemist I, Contract (April 1996 – June 1997)
Responsible for Solids, Liquids, and Chemical Component analyses according to applicable Method Specification, compendia, and cGMP / GLP requirements in order to meet established release metrics.
Professional Credentials
Process Excellence Practitioner Certification (April 2009)
Collaborator of the Month (Jan 2009)
Symphony Leadership Training (2008)
Developed reagent labeling system that was recommended to be a benchmark at other J&J facilities across the network (2004)
Laboratory Chemical Hygiene Officer (2002 – Present)
References Available upon Request
Skills:
-QC Analytical Laboratory Management; Pharmaceutical
-People Talent Development
-Deviation Investigations
-Analytical Data Review
-SAP
-LIMS
-Technical Writing
-PE / Six Sigma (5s, kaizen projects, Value Stream Mapping, SIPOC)
-Experience with FDA / MHRA inspections
-Marketed Product Stability Program
-Change Management
-Data Trending
-Team Development and Training
-Qualification and Validation document review
-Equipment Cleaning Validation
-Process Validation Protocols,
-Analytical Method Transfer protocols,
-Computer System Validations (Empower 2 Chromatography Data System)
-Laboratory Method Development / Method Transfers
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