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Manager Quality Assurance

Location:
Wooster, OH, 44691
Posted:
March 09, 2010

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Resume:

Kristin A. Feierabend

**** ********* **** . ********* *** . Wooster, OH 44691

Phone (330) 439 - 4303 . E-mail: abncdz@r.postjobfree.com

BACKGROUND SUMMARY:

Senior Associate level analytical chemist with proven ability to learn

quickly, optimize procedures, as well as coordinate and implement projects

with efficiency. Strengths include:

Analytical chemistry testing in a regulatory environment

Diligent, goal-oriented leadership

Ability to multi-task while devoting attention to detail

EDUCATION:

B.S., Chemistry; Furman University, Greenville, SC 2002

EXPERIENCE:

Amgen, Inc. Longmont, CO

Senior Associate QAL (Raw Materials/Analytical Support Group) 2006 to 2009

. Conducted testing of raw materials and provided analytical support in a

FDA-regulated cGMP environment

. Managed scheduling of raw materials testing among group to meet testing

turnaround goals

. Performed compendial and non-compendial laboratory procedures including

acid-base, complexometric, potentiometric, iodometric, and Karl Fischer

titrations, pH, conductivity, UV-Vis spectrophotometry, GC, GC-MS, optical

rotation, wet chemistry and near-infrared ID tests, gravimetric analyses,

melting range, limit tests including heavy metals, arsenic, iron,

chlorides, and sulfates as well as other methods

. Supervised laboratory safety as the Group Safety Officer with monthly

inspections, job hazard assessments, and training

. Reviewed colleagues' assays for accuracy and compliance

. Assisted Amgen near-infrared (NIR) global technical expert in creation of

raw material ID library and provided support for cross-site implementation

. Wrote and revised control documents including SOPs, analytical methods,

and laboratory procedures used in cGMP operations and testing

. Executed ICP-MS, GC, and GC-MS investigational testing and studies that

led to implementation of new procedures and standards

. Provided troubleshooting for instrumentation including Near-IR and UV-Vis

spectrometers and GC

. Trained analysts in raw material laboratory testing

. Compiled and managed reference standard database

. Audited group's laboratory notebooks for cGMP compliance, performed

equipment maintenance through work-order completion, provided LIMS

support, created and maintained equipment logbooks, and cataloged the

receipt of raw materials

. Procured specialty glassware, lab supplies, and reagents

Act 1 and Lancaster Laboratories contracting for Amgen, Inc. Longmont, CO

Chemist (Raw Materials/Analytical Support Group) 2003 to 2006

. Conducted testing of raw materials in a FDA-regulated cGMP environment

. Performed compendial and non-compendial laboratory procedures including

acid-base, complexometric, potentiometric, iodometric, and Karl Fischer

titrations, pH, conductivity, UV-Vis spectrophotometry, optical rotation,

wet chemistry ID tests, gravimetric analyses, melting range, limit tests

including heavy metals, arsenic, iron, chlorides, and sulfates as well as

other methods

. Audited laboratory notebooks for cGMP compliance

. Compiled and managed reference standard database

. Trained analysts in raw material laboratory testing

. Utilized skills including technical writing, as well as documenting,

computing, interpreting, and entering data

. Developed and delivered technical presentations at departmental meetings

Lexmark Boulder, CO

Chemical Process Operator 2003

. Conducted analytical testing of anodizing baths for appropriate

conditions

. Performed techniques including acid-base titrations, pH and conductivity

measurements, and UV-Vis spectroscopy

. Conducted gloss, thickness, and admittance testing on anodized cores to

assure quality standards

. Modified anodizing conditions (concentration of reagents, bath

temperature, and pH) to maintain optimum conditions

. Operated robotic machinery facilitating anodization

. Processed chemical waste for safe disposal

Development Department, Furman University Greenville, SC

Furman Fund Student Assistant 2001 - 2002

. Organized alumni gift documentation

. Researched missing alumni information

. Raised gifts for University via telephone

. Prepared fundraising letters

. Performed data-entry and filing tasks

. Aided in computer maintenance

Chemistry Department, Furman University Greenville, SC

Undergraduate Research Assistant Summer 2000 & 2001

. Conducted research on antimicrobial plastics (polypropylene with

antimicrobial additive AlphaSan ) using Nanoscope III Multimode Atomic

Force Microscope (AFM) for Milliken Chemical Company

. Resolved sample preparation issues through various experimental

techniques

. Developed and implemented quantitative and qualitative analysis of

AlphaSan surface distribution

. Extended AlphaSan analysis to include its characterization in other

plastics: Acrylic, LPDE, PET, Polystyrene, and Nylon

. Continued prior student's research in the synthesis of novel platinum-

containing complexes

Coastal Center for Environmental Health and Biomolecular Research

National Ocean Service, NOAA Charleston, SC

Administrative Assistant Summer 1998, 1999

. Provided services such as faxing, package shipping, bookbinding,

photocopying, answering telephones, database entry, and guest relations

AWARDS and MEMBERSHIPS:

. Amgen Excellence in Operations Award 2008 - Honorable Mention in Cross-

Site Collaboration for the Bruker NIR Global Instrument Validation Team

. Lancaster Superlative Service Award - May 2005

. Member, American Chemical Society - 2006 - Present

References for Kristin A. Feierabend

2500 Cleveland Road . Apartment 404 . Wooster, OH 44691

Phone (330) 439 - 4303 . E-mail: abncdz@r.postjobfree.com

Professional Contacts

Mike Bauman

Manager QAL

Amgen

4000 Nelson Rd.

Longmont, CO 80503

Work Phone: (303) 401 - 1355

Cell Phone: (303) 619 - 4631

E-Mail : abncdz@r.postjobfree.com

Kimberly Stough

Senior Associate QAL

Amgen

4000 Nelson Rd.

Longmont, CO 80503

Work Phone: (303) 401 - 7582

Cell Phone : (303) 885 - 3453

E-Mail : abncdz@r.postjobfree.com

Kevin Kelley

Senior Associate QAL

Amgen

4000 Nelson Rd.

Longmont, CO 80503

Work Phone: (303) 401 - 2442

Cell Phone : (303) 229 - 4487

E-Mail : abncdz@r.postjobfree.com

Kristy Vrkljan

Manager for Lancaster Labs

Now a Quality Assurance Manager

For ChromaDex, Inc

2830 Wilderness Pl,

Boulder, CO 80301

Work Phone: (303) 442 - 4281 Ext. 226

Cell Phone: (720) 324 - 3793

E-Mail : abncdz@r.postjobfree.com

Personal Contacts

Maria Kiehling

Legal Assistant

1101 Grove Park Drive

Charleston, SC 29414

Work Phone: (843) 856 - 4488

Cell Phone: (843) 697 - 0038

E-Mail : abncdz@r.postjobfree.com

Laura Dubois

Laboratory Research Associate II

4112 Lazyriver Lane

Durham, NC 27712

Home Phone : (919) 402 - 9229

Cell Phone : (919) 452 - 8270

E-Mail : abncdz@r.postjobfree.com

Jenny David

Exercise Specialist

2408 Weaver Dr.

Wooster, OH 44691

Cell phone : (919) 510 - 0554

E-Mail : abncdz@r.postjobfree.com



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