Experience:Quality Assurance and Analytical/Bioanalytical Specialist• Provided contracted quality assurance support for commercial manufacturing of drugs and consumer products.• Managed quality assurance and bioanalytical projects to support R&D activities at a global Fortune 100 pharmaceutical leader.• Active member on multi-functional project teams requiring frequent interactions with contractors and internal colleagues in order to meet project objectives and timelines.• Ensured compliance to government regulations, company policies, SOPs, and product specifications.• Released pharmaceutical products for clinical usage according to specifications.• Authored specifications/instructions for pharmaceutical products and ingredient analysis.• Validated bioanalytical methods, performed trace analysis, interpreted and reported results from pharmaceutical and related metabolite analysis in biological matrices.• Supervised analytical staff conducting testing under GMP and GLP conditions.Goals:Professional position in the fields of Quality Assurance, Bioanalytical Chemistry, or Analytical Chemistry.Specialties: Quality Assurance (GMP manufacturing/packaging); Bioanalytical Chemistry (method development/validation and sample analysis); Management of contracted bioanalytical analyses; Biopharmaceutics/Bioavailability-Pharmacokinetics.
Listed skills include Pharmaceutical Industry, Gmp, Glp, Analytical Chemistry, and 13 others.