Friends (1)

Amy Bledsoe

Freelance Editor & Proofreader

Location:Kansas City, Missouri, United States
2 Skills

B.S., Biology, Park University, Parkville, Missouri, 2002


• Manufacturing Quality Control/Quality Assurance
• Knowledge of compendial methods and general chapters (USP, EP, JP, BP, FCC)
• Knowledge of proper SOP execution
• Writing IQ/OQ/PQ methods
• GC (including head space)
• Karl Fischer titration
• Titrations (acid-base and coulometric)
• UV/Vis
• Solution preparation (including mobile phase)
• Extractions
• Thermogravimetric analysis (TGA)
• Infrared spectroscopy (FTIR)
• Dissolution
• Subvisual particle counting (using HIAC and Coulter)
• Determination of pH (using digital pH meter and electrode)
• General biology including embryology, cell/molecular biology, and anatomy/physiology


Quality Control/Quality Assurance Manager, B.F. Ascher & Co., Inc – May 2013 – Oct 2018
Managed Quality Control (QC) lab with 2 chemists, 1 lab tech; conducted internal audits of production, shipping/receiving, lab; developed and implemented quality assurance methods, procedures, and systems, including IQ/OQ/PQ methods for HPLC and GC; conducted on-site contract manufacturer’s audits; participated in FDA audit(s); conducted cGMP training for all production, shipping, receiving, and lab personnel; responsible for: all cGMP compliance and training, all aspects of master batch records (creation, review, release of product), review/approval/creation of master batch records, continued adherence to SOPs, analytical methods, procedures, validations (method and instrument), verifications, qualifications, calibrations

Quality Control Chemist, October 2011 – May 2013
Bayer Animal Health (via Aerotek Scientific)
Quality control testing, preparation, analyses and final result calculations of many types of analytical samples including raw materials, stability samples, and active pharmaceutical ingredients in manufacturing as well as method development and method transfer using: HPLC, GC (including head space), Karl Fischer (volumetric and coulometric), FT-IR, UV, Laser Particle Counting (Coulter), Sieve analysis, Titrations (acid-base, and potentiometric), TLC, extractions, refluxing, dissolution, bench and wet chemistry for identification

Quality Control Chemist, September 2008 – February 2011
Church & Dwight, Harrisonville, Missouri
Quality control testing of all laundry detergent product using: HPLC, viscometer, auto-titrator, moisture analyzer, pH, Microsoft Excel

QC Scientist, July 2007 – July 2008
Aptuit, Harrisonville, Missouri
Quality control testing of raw materials and active pharmaceutical ingredients in manufacturing using: HPLC, GC, Karl Fischer (volumetric and coulometric), FT-IR, UV, Titrations (acid-base, and potentiometric), TLC

Analytical Chemist, November 2006 – June 2007
Clinical Reference Labortories, Lenexa, Kansas
Prepared samples using SPE (under vacuum and positive pressure), Hamilton Star robotic pipettor, liquid-liquid extraction/digestion, set up and run LC/MS/MS to analyze samples, prepared quality control standards and internal standards, prepared organic and aqueous mobile phases, SOP editing

Senior Technician, August 2002- July 2006
Midwest Research Institute, Kansas City, Missouri

Responsible for upkeep and organization of the stability facility; checking the fume hoods and cold storage units in the laboratories; maintaining the glassware used; and performing analyses, tests, and instrumental equipment operation as needed. Analyzes compounds using a variety of methods and instrumental equipment, including differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), infrared spectroscopy (FTIR), dissolution, and preparation of mobile phases for high performance liquid chromatography (HPLC) and assay and impurity profiles via HPLC and computer-assisted data analyses using TurboChrom. Complies with current Good Manufacturing Practices (21 CFR Part 211) and Good Laboratory Practices.

Call Coordinator, 2001-2002
Cerner Corporation/Shared Solutions, Kansas City, Missouri

Answered calls from patients with multiple sclerosis regarding the therapy Copaxone (glatiramer acetate) and assessing whether they needed to speak with a registered nurse, get financial help, etc.

Clerical, 1998-2002
ProStaff Employment Services, Parkville, Missouri

Performed various clerical assignments, typing (~ 60 wpm), filing (alpha, numeric, alphanumeric), data entry (~11,000 ksh)

Lab Assistant, Teacher’s Aide, 1998-2002
Park University, Parkville, Missouri

Duties included preparing laboratories for classes, including but not limited to preparing solutions, agars, media, and cultures; retrieving specimens from museum; cleaning glassware, tables, counters, etc.; assisting in the organization of chemical supply storage, inventory of chemicals/substances, retrieving MSDS, and filing MSDS. Other duties included grading exams, quizzes, and homework from biology and chemistry classes.

Contract Secretary, 1997-1998
Mile Hi Contracting, Aurora, Colorado

Duties included typing, filing, answering phones, taking messages, connecting to voice mail/pagers, organization and maintenance of contract files, and copying construction plans.

Clerical, 1996-1997
AOC International, Denver, Colorado

Data entry, relief for phones, typing, filing, mass mailings.

Security Guard, 1995-1996
First Watch Security Services, Denver, Colorado

Armed security patrol, armed stationary post, unarmed stationary post.

Accounting Clerk, 1994-1995
DPI Dykstra, Inc., Denver, Colorado

Typing, filing, back-up receptionist (answered phones, took messages/voicemail), preliminary processing of client/vendor payments and accounts payable (data entry).

Professional Affiliations

American Chemical Society
Skills (2) Rating