Grand River Aseptic Manufacturing

Description

Address: 140 Front Ave SW #3, Grand Rapids, MI 49504 Phone: (616) 678-2400: : : : : Hours: Website: Place name: Category: : Website: http://www.grandriverasepticmfg.com/ Category: Manufacturer Suggest an editUnable to add this file. Please check that it is a valid photo. Unable to add this file. Please check that it is a valid photo. · Own this business?Add missing informationAdd business hours Unable to add this file. Please check that it is a valid photo. Questions & answers Ask a questionBe the first to ask a question Add a photoThanks for sharing!Your photo will be posted publicly on Google.Contribute MoreDoneUpload public photos of Grand River Aseptic Manufacturing Posting publicly on the Web Write a review Reviews 1 Google review

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Grand River Aseptic Manufacturing Employees

Employee
Years
Job
Industry
Amy Kang Amy Kang Greater Grand Rapids, Michigan Area Details
Amy Kang's Grand River Aseptic Manufacturing Experience January 2014 - July 2015
Job Quality Assurance │ Continuous Improvement │ Pharma │ Medical Device│ Manufacturing
Industry Pharmaceuticals
Experience
Vention Medical  August 2015 - Present
SunMED Medical Solutions  July 2015 - August 2015
Grand River Aseptic Manufacturing   January 2014 - July 2015
Baxter International Inc.  October 2010 - January 2014
Plasma Biologic Services   August 2009 - April 2010

Skills
PMDA, FDA, JD Edwards, Seibel, Trackwise, Microbiology Cultures, Aseptic techniques, Aseptic Processing, Microsoft Office, Sharepoint, MDRs, Acceptable Quality Limit, SOP, Quality Assurance, Regulatory Submissions, Medical Devices, Documentation, Process Improvement, Protocol, GMP, Quality System, CAPA, Training, Regulatory Affairs, 21 CFR Part 11, Quality Auditing, Pharmaceutical Industry, Internal Audit, ISO, Root Cause Analysis, Change Control, Validation, Quality Control

Education
DePaul University   2004 — 2007
Bachelors of Science, Biology, General

DePaul University

Danny Karadsheh Danny Karadsheh Caledonia, Michigan Details
Danny Karadsheh's Grand River Aseptic Manufacturing Experience July 2015 - Present
Job Production Operator at Grand River Aseptic Manufacturing
Industry Biotechnology
Experience
Grand River Aseptic Manufacturing   July 2015 - Present
American Red Cross  June 2014 - May 2015
Central Michigan University  August 2013 - May 2015
McLaren Central Michigan  May 2014 - August 2014

Skills
Research, Public Speaking, PowerPoint, Microsoft Word, Microsoft Excel, Time Management, Social Media, Public Health, Employee Training, Communication, Team Leadership, Group Work, Group Projects, Group Presentations, Laboratory Skills, Customer Service, Laboratory Techniques, Laboratory Safety, Management, Leadership, Teamwork, Microsoft Office, Critical Thinking

Education
Central Michigan University   2010 — 2015
Bachelor's Degree, Biological and Biomedical Sciences

Grand Rapids Christian High School   2006 — 2010
High School

Kim Stringham Kim Stringham Greater Grand Rapids, Michigan Area Details
Kim Stringham's Grand River Aseptic Manufacturing Experience January 2014 - April 2015
Job Purchasing Agent at Van Andel Institute
Industry Research
Experience
Van Andel Institute  April 2015 - Present
Grand River Aseptic Manufacturing   January 2014 - April 2015
Grand River Aseptic Manufacturing   June 2013 - December 2013
Cerep  January 2008 - February 2013
Cerep  November 2004 - January 2008
Cerep  March 2002 - November 2004
Northern Trust  May 2001 - December 2001

Skills
Procurement, Quality Control, Laboratory Safety, CRO, Commercialization, Sop, Biotechnology, Lifesciences, Purchasing, Pharmaceutical Industry, Supplier Negotiation, Laboratory Equipment, Bill of Materials, Quality Assurance, Technical Writing, GMP, HPLC, Contract Manufacturing, cGMP manufacturing, Data Analysis, FDA, GLP, Laboratory, Life Sciences, SOP

Education
University of Michigan   1997 — 2001
Bachelor of Science (B.S.), Biochemistry

Amanda Hawkins Amanda Hawkins Greater Grand Rapids, Michigan Area Details
Amanda Hawkins's Grand River Aseptic Manufacturing Experience March 2015 - Present
Job Manager of Aseptic Manufacturing
Industry Pharmaceuticals
Experience
Grand River Aseptic Manufacturing   March 2015 - Present
Grand River Aseptic Manufacturing   May 2011 - Present
Grand River Aseptic Manufacturing   December 2010 - May 2011
Bristol-Myers Squibb  April 2008 - August 2010
Bristol-Myers Squibb  July 2004 - April 2008

Skills
GMP, Validation, SOP, Technology Transfer, Biotechnology, Pharmaceutical Industry, FDA, Quality System, Change Control, Manufacturing, CAPA, Biopharmaceuticals

Education
State University of New York College at Oswego   2000 — 2004
Bachelor of Arts, Biology

John Wichelt John Wichelt Kalamazoo, Michigan Area Details
John Wichelt's Grand River Aseptic Manufacturing Experience September 2014 - Present
Job Vice President of Client Pharmaceutical Services at Grand River Aseptic Manufacturing
Industry Pharmaceuticals
Experience
Grand River Aseptic Manufacturing   September 2014 - Present
Grand River Aseptic Manufacturing   June 2010 - September 2014
ProPharma Group  December 2004 - April 2010
Paladiem Technologies   2004 - 2004
PharmTech, Inc.   2002 - 2003
Abbott Laboratories  2000 - 2001
CTG  2000 - 2001
UIC - Joliet, IL   1995 - 1995

Skills
Quality Management, Quality Systems, Quality Assurance, Medical Devices, Validation, Start-ups, Management Development, ISO, Quality Auditing, ISO 13485, Supplier Quality, CAPA, Continuous Improvement, Turnarounds, Operations Management, Quality System, V&V, Change Control, R&D, 21 CFR Part 11, Pharmaceutical Industry, Document Management, Six Sigma, Project Management, Design Control, FDA, Regulatory Affairs, Aseptic Processing, LIMS, Software Documentation, FDA GMP, Biotechnology, GLP, Technology Transfer, Pharmaceutics, Analytical Chemistry, Lifesciences, Regulatory Requirements, GAMP, GxP, Regulatory Submissions, Clinical Trials, Cleaning Validation, Quality Control, GCP, Root Cause Analysis, Biopharmaceuticals, Computer System..., Process Simulation, GMP

Education
Colorado Technical University   2008 — 2009
Bachelor of Business Administration (B.B.A.), Science Project Management, 3.75

Colorado Technical University   2007 — 2008
Associates, Science

Western Illinois University   1990 — 1991

Ashley Pelfrey Ashley Pelfrey Grand Rapids, Michigan Details
Ashley Pelfrey's Grand River Aseptic Manufacturing Experience July 2015 - Present
Job Quality Engineer at Grand River Aseptic Manufacturing
Industry Pharmaceuticals
Experience
Grand River Aseptic Manufacturing   July 2015 - Present
Grand River Aseptic Manufacturing   February 2014 - July 2015
Grand River Aseptic Manufacturing   June 2013 - February 2014
Terumo Cardiovascular Systems  August 2012 - June 2013
Expertcare  October 2011 - September 2012
Expertcare  March 2012 - August 2012
Centerline Veterinary Hospital   October 2006 - August 2009

Skills
GMP, Quality Assurance, V&V, Medical Devices, Laboratory, Validation, Quality System, Technical Writing, Change Control, Root Cause Analysis, Microsoft Office, Computer System..., GDP, Organization, Test Methodologies, Aseptic Technique, Document Review, Laboratory Testing, Team Leadership, Time Management, Process Validation, Equipment Validation, Calibration, Risk Assessment, Protocol Development, FDA, CAPA

Education
Aquinas College   2007 — 2010
Bachelor of Science (B.S.), Biology, Chemistry

Chris Waldo Chris Waldo Greater Grand Rapids, Michigan Area Details
Chris Waldo's Grand River Aseptic Manufacturing Experience February 2008 - December 2010
Job Knowledgebase Manager at Peckham, Inc.
Industry Information Technology and Services
Experience
Peckham, Inc.   September 2014 - Present
Ranir LLC  September 2013 - September 2014
Stryker  February 2013 - September 2013
Aspen Surgical  December 2010 - September 2012
Grand River Aseptic Manufacturing   February 2008 - December 2010
Prima Communications, Inc.   2002 - February 2008
Sarcom  1997 - 2001
Fennville High School   1994 - 1996

Skills
GMP, ISO 13485, 510 K, Project Management, Process Analysis, Validation, FDA, Sop, Quality System, Quality Assurance, Change Control, Document Management, Technical Writing, Software Documentation, CAPA, 21 CFR Part 11, Process Improvement, Pharmaceutical Industry, Medical Devices, Regulatory Affairs, Complaint Management, Manufacturing, Training, V&V

Education
Central Michigan University   1989 — 2003
B.S., Secondary Education, English, Spanish, Bilingual Education

Ionia High School   1984 — 1988
Diploma

Joseph Redford Joseph Redford Greater Grand Rapids, Michigan Area Details
Joseph Redford's Grand River Aseptic Manufacturing Experience January 2015 - Present
Job Project Manager at Grand River Aseptic Manufacturing
Industry Pharmaceuticals
Experience
Grand River Aseptic Manufacturing   January 2015 - Present
Grand River Aseptic Manufacturing   January 2014 - January 2015
Grand River Aseptic Manufacturing   April 2013 - January 2014
Grand River Aseptic Manufacturing   April 2012 - April 2013
Grand River Aseptic Manufacturing   June 2011 - April 2012
Ferris State University  October 2010 - April 2011

Skills
GMP, Manufacturing, Aseptic Technique, Formulation, Biotechnology, Aseptic Processing, Deviation Management, CAPA, Technology Transfer, Validation, GLP, Software Documentation, SOP, FDA, Pharmaceutical Industry, Lyophilization, Quality System, Change Control

Education
Ferris State University   2006 — 2011
Bachelors of Science, Biotechnology

Jake VanBelzen Jake VanBelzen Philadelphia, Pennsylvania Details
Jake VanBelzen's Grand River Aseptic Manufacturing Experience May 2012 - March 2013
Job Postbaccalaureate Researcher at University of Pennsylvania
Industry Research
Experience
University of Pennsylvania  October 2013 - Present
Grand River Aseptic Manufacturing   May 2012 - March 2013
Ferris State University  October 2010 - May 2012
Walt Disney World  June 2011 - January 2012

Skills
GMP, Laboratory

Education
Ferris State University   2007 — 2013
Minor, Spanish Language and Literature

Ferris State University   2007 — 2012
Bachelor of Science (BS), Biotechnology

Amber Wisniewski Amber Wisniewski Comstock Park, Michigan Details
Amber Wisniewski's Grand River Aseptic Manufacturing Experience April 2015 - Present
Job Production Operator at Grand River Aseptic Manufacturing
Industry Hospital & Health Care
Experience
Grand River Aseptic Manufacturing   April 2015 - Present
Michigan Blood  May 2012 - April 2015
HMSHost  February 2009 - May 2012
ISIS Education   February 2008 - May 2008

Skills
Laboratory, Writing, Time Management, Teamwork, PowerPoint, Microsoft Word, FDA, Leadership, Research, Team Building, Event Planning, Mentoring, Teaching

Education
Grand Valley State University   2013 — 2015
Biomedical Sciences

Grand Rapids Community College
Associate's Degree, Biology, General

Sean Van Aken Sean Van Aken Des Moines, Iowa Details
Sean Van Aken's Grand River Aseptic Manufacturing Experience January 2014 - June 2014
Job Des Moines University, College of Podiatric Medicine and Surgery Class of 2018
Industry Medical Practice
Experience
American Podiatric Medical Student Association   October 2014 - Present
Grand River Aseptic Manufacturing   January 2014 - June 2014
Pauls Quality Collision   April 2013 - August 2013

Skills
Biomedical Sciences, Laboratory Skills, Sales, Statistics, Mathematics, Chemistry, Microsoft Excel, Social Media, Public Speaking

Education
Des Moines University   2014 — 2018
DPM, Podiatric Medicine/Podiatry

Grand Valley State University   2010 — 2013
Bachelor of Science (B.S.), Biological and Biomedical Sciences

Nicole Ebenhoeh Nicole Ebenhoeh Lansing, Michigan Details
Nicole Ebenhoeh's Grand River Aseptic Manufacturing Experience January 2013 - October 2013
Job QC Tech. EM at Emergent Biosolutions
Industry Pharmaceuticals
Experience
Emergent BioSolutions  October 2013 - Present
Grand River Aseptic Manufacturing   January 2013 - October 2013
Fox and Company  December 2011 - July 2012
Spectrum Health  May 2010 - August 2011

Skills
SOP, Quality Assurance, Quality Control

Education
Grand Valley State University   2007 — 2012
Bachelor of Science (BS), Biomedical Sciences, General

Tyler Pokley Tyler Pokley Wyoming, Michigan Details
Tyler Pokley's Grand River Aseptic Manufacturing Experience January 2014 - June 2015
Job Production Operator at Grand River Aseptic Manufacturing
Industry Pharmaceuticals
Experience
UPS  August 2015 - Present
Donald Baker Mason Contractors   July 2015 - Present
Grand River Aseptic Manufacturing   January 2014 - June 2015
Dickinson Press Inc.  August 2013 - January 2014
UPS Supply Chain Solutions  July 2013 - August 2013
Primerica  March 2011 - June 2013

Skills
Aseptic Technique, Aseptic Processing, Customer Service, Personal Finance, Sales, Insurance, Process Improvement, Microsoft Excel, Microsoft Word, Cold Calling, Manufacturing, Time Management, Leadership, Shipping, Operations Management, Forecasting, Transportation, Pharmaceutical Industry, Logistics

Education
Grand Valley State University   2015 — 2019
Bachelor of Engineering (B.E.), Electrical and Electronics Engineering

Grand Valley State University   2010 — 2013
Bachelor of Science (BS), Biomedical Sciences, General

University of Michigan   2007 — 2010

Amanda Liley Amanda Liley Lewisville, Texas Details
Amanda Liley's Grand River Aseptic Manufacturing Experience May 2012 - January 2015
Job Experienced GMP manufacturing QA Specialist
Industry Biotechnology
Experience
Gradalis Inc.  April 2015 - Present
Grand River Aseptic Manufacturing   May 2012 - January 2015
SPI Pharma  January 2011 - May 2012
Amway  June 2009 - November 2010

Skills
FDA, Quality Assurance, GMP, Validation, CAPA, GLP, Pharmaceutical Industry, Quality System

Education
Grand Valley State University   2005 — 2009
Cell and Molecular Biology

Cliff Muller, CPMM Cliff Muller, CPMM Greater Grand Rapids, Michigan Area Details
Cliff Muller, CPMM's Grand River Aseptic Manufacturing Experience April 2013 - Present
Job Cliff Muller is a Facility Engineer at Grand River Aseptic Mfg
Industry Pharmaceuticals
Experience
Grand River Aseptic Manufacturing   April 2013 - Present
Pfizer  April 2001 - November 2012
The Upjohn Company  January 1989 - May 2001
Pharmacia & Upjohn  May 1996 - May 1998

Skills
Facilities Management, Maintenance Management, Facilities Engineering, Strategic Planning, CMMS, Physical Asset..., Preventive Maintenance, Predictive Maintenance, Plant Maintenance, Building Maintenance, Reliability Centered..., CAD, Professional..., Non-profit Experience, Digital Photography, Audio Mixing, Reliability, Project Planning, Reliability Engineering, Budgets, CAD Standards, Commissioning, Team Building, Process Scheduler, Leadership, HVAC, Change Control, Continuous Improvement, Maintenance & Repair, Management, Root Cause Analysis, Engineering, Manufacturing

Education
Western Michigan University   1979 — 1986
Bachelor of Science (BS), Engineering Graphics

University of Dayton   1995 — 1999
License in Manufacturing Reliability, Center for Competitive Change

Jennifer Wetzel Jennifer Wetzel Kalamazoo, Michigan Details
Jennifer Wetzel's Grand River Aseptic Manufacturing Experience January 2014 - Present
Job QC Micro Tech at Grand River Aseptic Manufacturing
Industry Pharmaceuticals
Experience
Grand River Aseptic Manufacturing   January 2014 - Present
Pfizer  April 2011 - January 2014
Amway  September 2009 - March 2011

Skills
GMP, Sop, GLP, Pharmaceutical Industry, Biotechnology, Clinical Trials, Validation, LIMS, Lifesciences

Education
University of Michigan-Dearborn   2003 — 2008
Bachelor of Applied Science (B.A.Sc.), Biology, General

Airport High School   1999 — 2003

Dilip Ayyala Somayajula, CPIP Dilip Ayyala Somayajula, CPIP Grand Rapids, Michigan Details
Dilip Ayyala Somayajula, CPIP's Grand River Aseptic Manufacturing Experience June 2013 - Present
Job Validation Manager at Grand River Aseptic Manufacturing
Industry Pharmaceuticals
Experience
Grand River Aseptic Manufacturing   June 2013 - Present
NantPharma  December 2012 - May 2013
NantPharma (fka Active BioMaterials)   November 2010 - December 2012
Akorn, Inc  October 2009 - November 2010
Valimation   March 2008 - October 2009
Momentive Performance Materials  May 2007 - December 2007
Cleveland Clinic  February 2006 - May 2007
Indian Immunologicals Limited  2003 - 2005

Skills
Cleaning Validation, Computer System..., 21 CFR Part 11, Quality Management, CAPA, GAMP, GxP, Software Validation, Six Sigma, DMAIC, Control Charts, Gage R&R, Hypothesis Testing, Process Capability, ANOVA, Process Validation, Protocol Writing, Equipment Installation, Chemical Engineering, Pilot Plant, Equipment Specification, P&ID, Electronic Signatures, Validation, SOP, FMEA, LIMS, Design of Experiments, SPC, Commissioning, cGMP, Quality Systems, Pharmaceuticals, Technology Transfer, Quality Assurance, GLP, Change Control, Root Cause Analysis, Aseptic Processing, Continuous Improvement, Technical Writing, Minitab, Risk Assessment, Sop, GMP, V&V, Pharmaceutical Industry, FDA, Quality System, Sterilization

Education
Cleveland State University   2006 — 2008
MS, Chemical Engineering

Jawaharlal Nehru Technological University   1999 — 2003
Bachelors, Chemical Engineering

St.Meeras   1992 — 1997
High School

Steven Nole Steven Nole Grand Rapids, Michigan Details
Steven Nole's Grand River Aseptic Manufacturing Experience February 2015 - Present
Job Director of Manufacturing Operations at Grand River Aseptic Manufacturing
Industry Biotechnology
Experience
Grand River Aseptic Manufacturing   February 2015 - Present
Anika Therapeutics  May 2014 - February 2015
Pfizer  November 2012 - May 2014
Pfizer  July 2007 - December 2012
Pfizer  January 2004 - July 2007
Pfizer  January 2002 - January 2004
King Pharmaceuticals  October 2001 - January 2002
King Pharmaceuticals  March 1999 - October 2001

Skills
Technology Transfer, Sop, GMP, Aseptic Processing, Biopharmaceuticals, Pharmaceutical Industry, FDA, Quality Assurance, Formulation, Pharmaceutics, CAPA, Quality Control, SOP

Education
Oakland University   1995 — 1998
Biology

Dave Felicelli Dave Felicelli Greater Grand Rapids, Michigan Area Details
Dave Felicelli's Grand River Aseptic Manufacturing Experience 2014 - Present
Job Senior Chemist at Grand River Aseptic Manufacturing
Industry Pharmaceuticals
Experience
Grand River Aseptic Manufacturing   2014 - Present
Ranir LLC  2010 - 2014
Perrigo  2008 - 2010
American Pharmaceutical Partners  2002 - 2005
Abbott Laboratories  1993 - 2000

Skills
FDA, GMP, Regulatory Affairs, Pharmaceutical Industry, Quality Assurance, Lean Manufacturing, Design of Experiments, HPLC, MS Project, Project Management, FMEA, Analytical Method..., Chemical Formulation, GC-FID, Project Scope..., Process Verification, Capital Projects, Test Lab Management, Microsoft Project, CAPA, Analytical Chemistry, Laboratory, GLP, Formulation, SOP, R&D, Computer System..., Validation, Equipment Qualification, Laboratory Informatics

Education
Alma College   1989 — 1993
B.S., Chemistry, Economics

Judy Meyers Judy Meyers Indianapolis, Indiana Area Details
Judy Meyers's Grand River Aseptic Manufacturing Experience August 2014 - Present
Job Business Development at Grand River Aseptic Manufacturing
Industry Program Development
Experience
Grand River Aseptic Manufacturing   August 2014 - Present
Cook Pharmica  June 2009 - February 2014
Cook PharmBusines   August 2008 - June 2009
Baxter Healthcare  2001 - 2007
St. Vincent Hospital  1982 - 1999
St.Vincenct Hospital   1988 - 1995

Skills
Pharmaceutical Industry, Change Control, GMP, Healthcare, Biotechnology, Biopharmaceuticals, FDA

Education
Indiana Wesleyan University   1995 — 1999
Business Administration and Management, General

Nick Bykerk, CPA Nick Bykerk, CPA Greater Grand Rapids, Michigan Area Details
Nick Bykerk, CPA's Grand River Aseptic Manufacturing Experience August 2012 - Present
Job Controller at Grand River Aseptic Manufacturing
Industry Accounting
Experience
Grand River Aseptic Manufacturing   August 2012 - Present
Lakewood Process Machinery LLC  May 2011 - August 2012
Plante & Moran  January 2006 - October 2011

Skills
GAAP, Auditing, Tax, Internal Controls, Accounting, Financial Reporting, Financial Statements, Financial Accounting, Tax Preparation, Tax Returns, Fixed Assets, Assurance, Financial Analysis, Income Tax, Sarbanes-Oxley Act, CPA, Tax Research, US GAAP, General Ledger, QuickBooks, Finance, Microsoft Excel, Budgets, Account Reconciliation, Accounts Payable, Accounts Receivable

Education
Calvin College   2003 — 2007
Bachelor of Science (B.S.), Public Accounting

Ryan Bartolotti Ryan Bartolotti Greater Grand Rapids, Michigan Area Details
Ryan Bartolotti's Grand River Aseptic Manufacturing Experience August 2015 - Present
Job Quality Control Chemist
Industry Biotechnology
Experience
Grand River Aseptic Manufacturing   August 2015 - Present
Quest Diagnostics  January 2012 - March 2015
Quest Diagnostics  June 2007 - January 2012
Sparrow Health System  May 2004 - June 2007
Sparrow Health System  March 2003 - March 2004

Skills
Process Improvement, Quality Management, Laboratory Medicine, Laboratory, Validation, Quality Assurance, Software Documentation, Healthcare Management, Medicine, Clinical Chemistry, Management, Team Leadership, Continuous Improvement, HIPAA, R, CLIA, Sop, FDA, LIS, Laboratory Safety, Clinical Research, Immunoassays, Immunochemistry, Hardware Diagnostics, Laboratory Automation, Assay Development, Supervisory Skills, Medical Technology, GLP, Laboratory Equipment, Toxicology, Immunology, EMR, ELISA, Biochemistry, Customer Service, Collaborative Problem..., Program Management, Product Development, Life Sciences, Biotechnology, Hospitals, Healthcare Information..., Data Analysis, Leadership, SOP, Quality Control, Chemistry, Six Sigma, Project Management

Education
Eastern Michigan University   2011 — 2014
Master of Science (MS), Quality Management, 3.6

Michigan State University   1999 — 2005
B.S., Medical Technology, 2.8

Leslie Nowicki Leslie Nowicki United States Details
Leslie Nowicki's Grand River Aseptic Manufacturing Experience January 2011 - January 2011
Job Consulting/contractor Validation services provider
Industry Medical Devices
Experience
Bio-Med Validation Services LLC   August 2012 - Present
Grand River Aseptic Manufacturing   January 2011 - January 2011
Regeneron Pharmaceuticals  October 2010 - December 2010
Hospira  August 2010 - September 2010
B.Braun Medical  May 2010 - July 2010
Black Diamond Network   March 2010 - April 2010
ValSource LLC  March 2008 - January 2010
GSK Bio Marietta with AVS   November 2006 - November 2007
Boston Scientific  March 2005 - October 2005
Eli Lilly and Company  2004 - 2005

Skills
Change Control, Software Documentation, 21 CFR Part 11, Medical Devices, Validation, Six Sigma, LIMS, Autoclave, Biotechnology, CAPA, Quality Assurance, HPLC, Pharmaceutical Industry, Computer System..., V&V, Quality System, Sop, Manufacturing, GMP, Design of Experiments, Commissioning, FDA, Quality Control, GxP, ISO 13485, Cleaning Validation, Biopharmaceuticals, GLP, Technology Transfer, GAMP, Regulatory Affairs, Automation, Process Simulation, Aseptic Processing

Education
State University of New York College at Brockport   1994 — 2000
Master of Science, Science Education

Tri-State University   1979 — 1984
Bachelor of Science, Chemical Engineering

Jeremy Griffin Jeremy Griffin Charleston, South Carolina Area Details
Jeremy Griffin's Grand River Aseptic Manufacturing Experience December 2012 - December 2014
Job Sr. Manager of Manufacturing at AAIPharma Services
Industry Pharmaceuticals
Experience
AAIPharma Services Corp.  January 2015 - Present
Grand River Aseptic Manufacturing   December 2012 - December 2014
Grand River Aseptic Manufacturing   December 2010 - December 2012
ProPharma Group  July 2006 - December 2010
CSL Behring  January 2005 - July 2006

Skills
Validation, Biotechnology, Commissioning, GMP, Quality Assurance, Chemistry, Process Validation, Documentation, cGMP, Software Documentation, V&V, 21 CFR Part 11, Computer System..., Quality System, FDA, GxP, Testing, CAPA, Quality Auditing, Change Control, Quality Control, Medical Devices, Manufacturing, GLP, Aseptic Processing, HPLC, Sop, Cleaning Validation, ISO 13485, LIMS, SOP

Education
Colorado Technical University   2007 — 2010
BS, Business (Project Management)

Colorado Technical University   2007 — 2010
Associate of Science, General Studies

Eric Isom Eric Isom Indianapolis, Indiana Area Details
Eric Isom's Grand River Aseptic Manufacturing Experience June 2014 - Present
Job Finishing Operations Manager at Grand River Aseptic Manufacturing
Industry Pharmaceuticals
Experience
Grand River Aseptic Manufacturing   June 2014 - Present
Sentry BioPharma Services, Inc.   2006 - June 2014
Baxter BioPharmaceutical Solutions LLC   June 1998 - February 2006

Skills
Warehousing, Supply Chain Management, Logistics, Supply Chain, Cold Chain, Microsoft Word, SQL, Crystal Reports, Access Database, Customer Service, Microsoft Excel, Human Resources

Education
Indiana State University - School of Business   1992 — 1995
Bachelors, Business Management

Vincennes University   1985 — 1988
AS, Law Enforcement

Brian Raymond Brian Raymond Greater Philadelphia Area Details
Brian Raymond's Grand River Aseptic Manufacturing Experience June 2012 - June 2013
Job SingleUse Sales Specialist at Pall Corporation
Industry Biotechnology
Experience
Pall Corporation  June 2013 - Present
Grand River Aseptic Manufacturing   June 2012 - June 2013
Grand River Aseptic Manufacturing   November 2010 - July 2012
ICF International  September 2006 - November 2010
WelSo Federal Services   March 2003 - September 2006

Skills
Validation, GMP, GLP, Quality Assurance, Product Development, Requirements Analysis, Chemistry, ISO 13485, Program Management, New Business Development, LIMS, Sop, GxP, FDA, Pharmaceutical Industry, Biologics, CAPA, Change Control, Biotechnology, 21 CFR Part 11

Education
Walsh College   2006 — 2009
MBA, Finance

Northern Arizona University   1999 — 2003
BS, Environmental Science w/ emphasis in chemistry

Johanna (Joni) Catanzarite-Pecsi Johanna (Joni) Catanzarite-Pecsi South Bend, Indiana Details
Johanna (Joni) Catanzarite-Pecsi's Grand River Aseptic Manufacturing Experience June 2012 - November 2013
Job Engineer
Industry Aviation & Aerospace
Experience
Honeywell Aerospace  June 2015 - Present
Maverick Packaging, Inc.   June 2014 - June 2015
SPI Pharma via Aerotek   January 2014 - May 2014
Grand River Aseptic Manufacturing   June 2012 - November 2013
KIK Custom Products  October 2011 - April 2012
KIK Custom Products  November 2001 - October 2011
Procter & Gamble  October 1995 - May 2001
Procter & Gamble  July 1994 - October 1995

Skills
Validation, HPLC, LIMS, Gas Chromatography, Wet Chemistry, GMP, UV/Vis, Chemistry, Quality Control, FDA, Laboratory, SOP, FTIR, Product Development, Analytical Chemistry, GLP, Method Development, USP, IR, Manufacturing, Cleaning Validation, Chemstation, TLC, Formulation, Raw Materials, FDA GMP, Pharmaceutics, Technology Transfer, Aseptic Technique, CAPA, Analytical Method..., Contract Manufacturing, GxP, Titration, V&V, UV, 21 CFR Part 11, Change Control, Pharmaceutical Industry, IR spectroscopy, Aseptic Processing, Pharmacueticals, Atomic Absorption, ICP-OES

Education
Indiana University South Bend   2007 — 2010
MBA, General

Indiana University South Bend   1988 — 1994
BS, Chemisrty

James Fife James Fife Charleston, South Carolina Area Details
James Fife's Grand River Aseptic Manufacturing Experience September 2009 - December 2012
Job Sr. Director, Parenteral Operations at AAIPharma
Industry Pharmaceuticals
Experience
AAIPharma  December 2012 - Present
Grand River Aseptic Manufacturing   September 2009 - December 2012
Amylin Pharmaceuticals  2005 - 2009
Akorn, Inc  2003 - 2005
Cardinal Health  1999 - 2003
Meridian Medical Technologies  1990 - 1999

Education
Southern Illinois University, Edwardsville   1983 — 1990

Sarah Waddell Sarah Waddell Greater Grand Rapids, Michigan Area Details
Sarah Waddell's Grand River Aseptic Manufacturing Experience June 2015 - September 2015
Job Internal Auditor at Perrigo
Industry Pharmaceuticals
Experience
Perrigo  October 2015 - Present
Grand River Aseptic Manufacturing   June 2015 - September 2015
Grand River Aseptic Manufacturing   April 2015 - June 2015
Perrigo  February 2013 - April 2015
Perrigo  March 2011 - February 2013
Perrigo  November 2010 - March 2011
Corium International  June 2009 - November 2010
Amway  April 2008 - April 2009

Skills
Validation, GMP, HPLC, Quality Assurance, Laboratory, UV/Vis, SOP, Quality Control, CAPA, FDA, Microbiology, Gas Chromatography, Wet Chemistry, Pharmaceutical Industry, Cleaning Validation, GLP, FTIR, Quality System, Quality Management, Change Control, Analytical Chemistry, Quality Auditing, Six Sigma, CSSGB, LIMS, 21 CFR Part 11, Chromatography, ASQ Member, Continuous Improvement, CQT, Chemistry, FDA GMP, Supervisory Skills, Green Belt, Empower, SAP, Electronic Lab Notebooks, Trackwise, Supplier Quality, Batch Records, Chemstation, Personnel Supervision, Aseptic Processing, Parenteral, Performance Management, Document Review, Master Control, Learning Management..., Internal Audit, SuccessFactors

Education
Eastern Michigan University   2012 — 2014
Master's Degree, Quality Management

Kalamazoo College   2001 — 2005
Bachelor of Arts, Biology

Valeria Dittrich Valeria Dittrich Greater Grand Rapids, Michigan Area Details
Valeria Dittrich's Grand River Aseptic Manufacturing Experience November 2011 - Present
Job Marketing Coordinator at Grand River Aseptic Manufacturing
Industry Pharmaceuticals
Experience
Grand River Aseptic Manufacturing   November 2011 - Present
Grand Valley State University Housing   August 2009 - August 2012
West Ottawa High School Womens Track   March 2010 - June 2012
Sofia Bella Couture   November 2011 - April 2012
Moms in Tow   September 2011 - December 2011
Technologic (Student Enterprise)   April 2011 - September 2011
Red Robin  August 2007 - August 2011

Skills
Social Media Marketing, Marketing, Social Media, Blogging, Social Networking, Advertising, Email Marketing, Spanish, Event Planning, Public Speaking, Brand Development, New Business Development, Customer Service, Management, Sales, Retail, Entrepreneurship, Coaching, Promotions, French, Lead Generation, Salesforce.com, Microsoft Office, Facebook, Microsoft Excel

Education
Grand Valley State University   2008 — 2012
Bachelor of Business Administration (B.B.A.), Marketing/Marketing Management, General

West Ottawa High School   2004 — 2008

Mark Crim Mark Crim Allegan, Michigan Details
Mark Crim's Grand River Aseptic Manufacturing Experience April 2011 - Present
Job
Industry Pharmaceuticals
Experience
Grand River Aseptic Manufacturing   April 2011 - Present

Skills
GMP

Education
Kalamazoo Valley Community College

Western Michigan University

Jane Monroe Jane Monroe Greater Grand Rapids, Michigan Area Details
Jane Monroe's Grand River Aseptic Manufacturing Experience May 2011 - January 2013
Job Planning Engineering Manager at Holland Board of Public Works
Industry Utilities
Experience
Holland Board of Public Works  January 2013 - Present
Grand River Aseptic Manufacturing   May 2011 - January 2013
Capital Projects & Facility Services   August 2011 - August 2012
Pfizer Pharmaceuticals  January 2001 - 2008
Pfizer Pharmaceuticals  1994 - 2001
Pfizer Pharmaceuticals  1991 - 1994
The Christman Company  1990 - 1991
Merrick & Company  1988 - 1990

Skills
Validation, Change Control, Manufacturing, Engineering, Document Management, GMP, Program Management, PMP, FDA, Project Management, Cross-functional Team..., Pharmaceutical Industry, Quality System, Six Sigma, Quality Assurance, Lean Manufacturing, Process Simulation, Leadership, Software Documentation, MS Project, Process Improvement, Sop, Continuous Improvement, Process Engineering, Construction, Quality Management

Education
Penn State University   1979 — 1984
B.S. Engineering