E. Teresa Janecki

 

Profile

 

Project Manager

Creative problem solver spearheads complex research and data analysis. Consistently executes critical tasks within aggressive timeframes. Strong communication skills with the ability to foster and maintain professional working relationships within all levels of an organization. Expertise in technical writing including writing, editing and formatting documents related to regulatory submissions.

 

Project Management ∙ Assay Development ∙ Technical Writing ∙ Detail Oriented

Interpersonal Skills ∙ Process Improvement ∙ Regulatory Compliance

 

Professional Experience

 

Sun Products Corporation

Salt Lake City, Utah        September 2014 – Present

 

QA Data Specialist

Responsible for execution of the supplier approval and qualification process.  Updating the supplier expectation manual sign off status and verifying active suppliers.  Use SAP QM module and Red Prairie warehouse management systems to generate reports and track metrics.  Developing Root Cause Analysis, (RCA), guidelines for input into Intelex quality management system.

§    Contact upper level management of Sun suppliers to obtain the Sun Self Assessment Questionnaire that is used to qualify and evaluate supplier during the approval process

§    Generate Soon to Expire, (STE), Report to provide visibility of inventory nearing the stop ship date and to assess priority of shipments

§    Work with management to develop a structured analysis for identifying causal factors and root causes of incidents with Sun suppliers

 

Watson Pharmaceutical / Kelly Scientific

Salt Lake City, Utah        November 2010 – December 2011

 

Technical Writer

Responsible for complex research and analysis of data, documentation and workflow for work processes in LiveLink document management system. Coordinated documentation review and sign off to meet aggressive FDA deadlines

§    Developed, wrote, updated and reviewed Standard Operating Procedures (SOP’s), Test Methods (TM’s) and Material Specifications (MS’s)

§    Prepared summary reports, graphs, charts and statistical analysis for establishing product specifications

Documentation Product Development Specialist

Provided overall coordination of Product Development documentation. Worked with many different departments throughout the country to manage these efforts.

§    Supported new SOP’s, Development Methods (DM’s) and MS issuance, change control review and routing for approval in LiveLink

§    Wrote documents specific to the CNC section of ANDA applications to FDA

§    Maintained departmental analytical documents including validation reports, development methods and database entry retrieval and archival

§     

Ingenix

Salt Lake City, Utah        November 2006 – December 2009

 

Sales Executive

Responsible for a $2.3 million book of business that includes 7 large healthcare systems, 2 are the largest in the United States, Community Health Systems, (CHS), and Hospital Corporation of America, (HCA)

§    Used excellent communication and persuasion skills to grow customer accounts by 17% in 2008 and 10% in 2009

§    Worked with all levels of healthcare providers, from Office Managers to C-Suite, offering over 400 different medical reference guides, billing and payment references and software applications to stay compliant with Centers for Medicare and Medicaid Services, (CMS), as well as maximize profitability.

§    Conducted WebEx and onsite demonstrations and training of software

 

BD Clontech

Mountain View, California            January 2004 – February 2004

 

QC Associate – Left due to family illness

Conducted quality control testing of molecular and cell biology products

§    Used technical expertise, product knowledge and communications skills to facilitate projects relating to testing of products

§    Interacted with several different departments including product management, R and D, Techcom and other operations groups to streamline and optimize processes and protocols

§    Wrote and edited SOP’s which included use of SAP applications to document problems, investigate and correct problems and plan preventative action.

§    Hands on bench work with testing and troubleshooting of products using cGMP

 

Lawrence Livermore National Laboratory

Livermore, California            February 2000 – January 2003

 

Biomedical Scientist

Developed airborne biological pathogen detection assays. Managed daily communications by way of progress reports with state, local governments and the Department of Defense.  Met very strict project deadlines involving sensitive national security issues.

§    Directed all aspects of development for the assay design and validation laboratory utilizing real time PCR technologies

§    Designed and executed assay protocols used to validate unique DNA signatures for several biological pathogens

§    Wrote critiques and presented technical data to members of field laboratories. Topics included proper use of various real-time PCR machines, robotic systems and software

§    Independently performed complex analysis of confounding regions in microbial genome sequence using multiple techniques including, Perl scripts and draft data

§    Selected candidates to build technical team

§    Developed computer code for data analysis

 

Myriad Genetics, Inc.

Salt Lake City, Utah    October 1994 – March 1999

 

Research Associate II

Discovered genetic mutations responsible for 10% of inherited breast and prostate cancers.

§    Conducted DNA amplification and sequencing for mutation screening of BRCA I & II genes

§    Designed primers and performed computer analysis of cDNA

§    Performed genotyping analysis of patient samples to generate linkage maps and LOD scores

 

University of Utah Medical Center

Salt Lake City, Utah       April 1988 - October 1991

 

Research Technician II

Howard Hughes Medical Institute,

University of Utah Medical Center

Extracted and purified bovine lipoprotein lipase.

Laboratory Technician

Maintained cell lines from mouse mammary tumors in vitro for radiation clonogenecity studies.

Purified DNA from frozen white blood cells and nuclei of lymphoblast cell lines.

 

Education

 

Bachelor of Science, Exercise and Sport Science

University of Utah, Salt Lake City

 

Publications

 

A candidate prostate cancer susceptibility gene at chromosome 17p. Nature Genetics 2001 Feb;27(2): 172-80 Tavtigian SV, Simard J, Teng DH,... (16) Janecki T,... (18), Labrie F, Skolnick MH, Neuhausen S, Rommens J, Cannon-Albright LA.

 

Genomic sequencing and analysis of the marine cyanobacterium, prochlorococcus marinus (MED4).

12^th International Genome Sequencing and Analysis Conference, Miami, FL, September 12-15, 2000.

Proc. 12^th International Genome Sequencing and Analysis Conference.  Stillwagen, S, Arellano, A, Burkhart-Schultz, K, Janecki, T, Erler, A, Mariero, L, Attix, C, Sanders, C, Do, L, Johnson, G, Sakaldasis, G, Regala, W, Duarte, S, Kobayashi, A, Larimer, F, Chisholm, S, Rocap, G, and Lamerdin, J. E. (2000).

 

Human mitogen-activated protein kinase 4 as a candidate tumor suppressor. Cancer Research

1997 Oct 1;57(19):4177-4182

Teng DH, Perry WL 3^rd, Hogan JK,... (13) Janecki T,... (21) Kyriakis JM, Avruch J, Bartel P,

Wong AK, Tavtigian SV, et al

 

Localization of SMAD5 and its evaluation as a candidate myeloid tumor suppressor. Cancer Research

1997 Sepl;57(17):3779-3783

Hejiik DP, Kottickal LV, Liang H, Fairman J, Davis T, Janecki T, Sexton D, Perry WL 3^rd, Tavtigian SV, Teng DH, Nagarajan L.

 

Generation of an integrated transcription map of the BRCA2 region on chromosome 13ql2-ql3.

Genomics 1996 Aug 15;36(1):86-99

Couch FJ, Rommens JM, Neuhausen SL,... (14) Janecki T,... (25) Simard J, et al

 

The complete BRCA2 gene and mutations in chromosome 13q-linked kindreds. Nature Genetics

1996 Mar;12(3):333-337

Tavtigian SV, Simard J, Rommens J, Couch F,... (21) Janecki T,... (25) Goldgar DE, et al