Quality Assurance, Compliance in Pharma, New Jersey

I bring over 15 years of hands-on and in-depth analytical experience. My accomplishments include: developing, designing and authoring test methods and subsequently writing the protocols for the validation reports for compliance. I am very knowledgeable about many analytical instrumentation and techniques (wet chemical testing following compendia testing, titrations, and strength and purity profiles for API & drug products by HPLC and Ion Chromatography). I reviewed other colleagues work for accuracy and completeness in accordance to product specifications and compliance. In addition I have reviewed submission reports to regulated agencies and responded to questions and comments. I was a very active participant in departmental audits.

Chemist