Managed QC team.Managed a staff of 4 to 6, ranging from laboratory assistants to research scientists.Write SOPs, Test Methods, and method validation reports and protocols.Draft customer qualification documents.Assist in training new staff.Responsible for small scale GMP production support for QC types of analyses.Developed ICP-OES methods for the quantitation of metals in API’s.Developed ICP-OES limit test methods for the analysis of residual metals in API’s.Responsible for the administration and maintenance of QC instruments.Additional Instrumentation Experience include: X-ray, Particle Size Analyzer, ICP, Polarimeter, TGA, DSC, Coulometric KF, Volumetric KF, HunterLab colorimeterResponsible for the review and approval of notebook pages in the group.Set up and purchase any needed additional equipment or instruments.Part of the team to interview prospective candidates.Involved in customer meetings to discuss project objectives and deliverables.Responsible for QC support to customer projects.

-Managed QC team.-Managed a staff of 4 to 6, ranging from laboratory assistants to research scientists.-Write SOPs, Test Methods, and method validation reports and protocols.-Draft customer qualification documents.-Assist in training new staff.-Responsible for small scale GMP production support for QC types of analyses.-Developed ICP-OES methods for the quantitation of metals in API’s.-Developed ICP-OES limit test methods for the analysis of residual metals in API’s.-Responsible for the administration and maintenance of QC instruments.-Additional Instrumentation Experience include: X-ray, Particle Size Analyzer, ICP, Polarimeter, TGA, DSC, Coulometric KF, Volumetric KF, HunterLab colorimeter-Responsible for the review and approval of notebook pages in the group.-Set up and purchase any needed additional equipment or instruments.-Part of the team to interview prospective candidates.-Involved in customer meetings to discuss project objectives and deliverables.-Responsible for QC support to customer projects.

Contract Research and Manufacturing Organization providing a full scale of services from early development to commercial API manufacturing.

-Knowledgeable in Laboratory Information Management Software (LIMS) which includes learning and writing analysis for validation.-Experienced in writing various correspondence, SOPs and routine reports.-Saved company over $100,000 in a single budget year on licensing fees from a lab software contract.-Effective communicator with technical and non-technical users.-Streamlined vendor relations and purchasing of supplies resulting in an improved turnaround time for lab work and a faster order fulfillment.-Purchased supplies for laboratory and scheduling maintenance of equipment. This involves dealing with various vendors and suppliers and negotiating pricing and terms.-Managed work performance of staff, performed corrections to their work and corrected lab page errors or procedure errors.-Reviewed chromatograms and approved data.-Wrote key SOP's relating to facility deficiencies in the area of in house qualified reference standards. Net result was saving millions on the budget.

Knowledgeable in Laboratory Information Management Software (LIMS) which includes learning and writing analysis for validation.Experienced in writing various correspondence, SOPs and routine reports.Saved company over $100,000 in a single budget year on licensing fees from a lab software contract.Effective communicator with technical and non-technical users.Streamlined vendor relations and purchasing of supplies resulting in an improved turnaround time for lab work and a faster order fulfillment.Purchased supplies for laboratory and scheduling maintenance of equipment. This involves dealing with various vendors and suppliers and negotiating pricing and terms.Managed work performance of staff, performed corrections to their work and corrected lab page errors or procedure errors.Reviewed chromatograms and approved data.Wrote key SOP's relating to facility deficiencies in the area of in house qualified reference standards. Net result was saving millions on the budget.

Managed a staff of 5 to 10 analysts. Managed their work performance, performed corrections to work and corrected lab page errors or procedure errors.Processed chromatograms and reported results. Involved in chromatogram archival.Involved in development of methods and their writing. Worked closely with clients on special projects utilizing their methods and making them more efficient.Received special training on: Waters Instrument (HPLC), Franz-cell Apparatus, Glove Box, Waters Expert Ease 860 Software and Waters Millennium Software.Check, process, present and report results for all outside client HPLC work. Answer inquiries of the FDA or client inspectors/auditors when required.

Bench work involved preparing samples as directed using USP/NF, BP, EP, FCC, ACS or current methods and run prepared samples on HPLC. Performed instrument maintenance.Performed problem solving and procedure changes as necessary.Processed chromatograms from run; developed methods as necessary; reported results.

Coordinated analysis according to written test procedures in USP/NF, BP, EP, FCC and ACS.Offered new suggestions for improvements in efficiency of testing, i.e. lab apparatus and equipment.Selected to learn new jobs and provide training for new employees.Assured product integrity through analysis of quality and technical requirements of the material.

Researcher of skin care products and provider of outside testing of chemicals and products.