Adam Sithe

**** ***** **

Indianapolis IN *****

1-513-***-****

E-mail acxxxz@r.postjobfree.com

INDUSTRIAL EXPERIENCE

Senior QA Inspector: Sigma-Tau Pharmasource Indianapolis IN. Nov 2010-Oct 2015

Performed all routine QA Inspector duties including:

Inspections of incoming Raw Materials and product components and enter data into SAP

Provide Real Time batch record reviews during manufacturing and packaging

operations to ensure prompt data review errors and omissions are detected

Perform investigations of QA deviations and other investigations such as customer complaints, production investigations, and enter into QTS system

Gather report and trend necessary metrics as required by QA Management e.g. cycle times of incoming raw materials and cycle times for batch records

Ensure all sample retains are logged in and stored according to SOPs and ensure

annual review of both finished packaged product retain samples and raw material samples on a quarterly basis

Performed Room releases and clearances in Production areas and areas requiring Clean Room attire

Train entry level QA Inspectors

QC Chemist: Schwarz Pharma, Seymour IN. Sept. 2009-Oct. 2010

Performed Analysis of both Release and stability samples for assay and

Content uniformity by HPLC

Performed Various Dissolutions including online Dissolutions

Performed Identity testing and other various wet chemistry testing

Analytical Chemist: Pantheon Pharmaceuticals, Cincinnati, OH. Mar 2007-Apr 2009

Analyzed cleaning and validation swabs for both Commercial and

Formulations Departments by HPLC using established test methods

Analyzed stability samples for assay by HPLC using established methods

QC Chemist for "Pilot Chemicals" Cincinnati, OH. Mar 1998-Sept 2006

Responsible for quality of incoming raw materials and finished products

Instruments include: GC, HPLC, Ion Exchange Chromatography,

UV-VIS and various wet chemistry tests involving surfactants

Quality Assurance Inspector, Forest Pharmaceuticals, Inc., Cincinnati, OH. Feb. 1995-Dec. 1997

Responsible for quality of all products manufactured and packaged at the

Cincinnati Plant, particularly solid dosage forms in accordance with cGMP,

Performed In-process checks for manufacturing and packaging processes

Performed sampling of incoming raw materials and finished products

Performed Stability sampling

Performed Line clearances and room releases for both packaging and Manufacturing

Wrote Investigations into batch deviations and out of specification results

Quality Control Assurance Chemist, Orchem, Inc., Fairfield, OH. Jan. 1992-Feb. 1994

Developed and implemented QC/QA procedures for all finished products and incoming raw materials to meet company goals and objectives

Developed and monitored production process procedures

Updated product formulations to meet individual customer needs

Designed Material Safety Data Sheets for new products and updated

existing ones as necessary

Provided technical support for field sales force and prepared field

sample test kits for their use

Instruments used

HPLC, GC, Ion exchange chromatography, AA Flame and Flameless, UV-Vis, Dissolutions and online Dissolutions

Software used

Empower, Chromeleon, LIMS, SAP, Microsoft word, PowerPoint, and Excel

EDUCATION

University of Cincinnati, Cincinnati, OH. B.S. Chemistry

University of Cincinnati, Cincinnati, OH. M.S. Chemistry

PROFESSIONAL ORGANIZATIONS

American Chemical Society

American Society for Quality Control

Contact this candidate