Aimee Olivares Email & Phone Number

Fairfield, Ca, Us

Novato

Novato, Ca

Napa, Ca

Manage QC chemistry/raw material personnel (20+). Manage decommissioning activities in QC laboratories. Maintain critical metric indicators. Key contributor for regulatory submission deliverables.

Napa, Ca

Ensured QC testing is accomplished and reported in a cGMP-compliant and timely manner, and that training requirements for laboratory personnel are met. Interpreted analytical test data and oversee/write OOS/OOT investigations, initiated non-conformances/deviations as applicable, and implemented corrective actions. Coordinated/performed lab safety, housekeeping, and regulatory audits. Reviewed and approved test data, protocols, and reports. Ensured preparation and maintenance of laboratory records. Created/revised/reviewed procedures. Modified/reviewed test requirements in response to compendial changes. Oversaw lab electronic information systems as well as implementation/qualification of analytical instruments (including 21 CFR part 11 impact).

* Validation of regulated computerized systems, software, automated equipment, utilities.* Created and executed validation protocols.* Reviewed, summarized and reported validation protocol data.* Created user requirements specifications, functional specifications, risk assessments, traceability matrices, and validation plans and reports.

* Millennium Chromatography Data System (CDS) application administrator and trainer* Team member/coordinator for validation of client/server chromatography data acquisition system* Troubleshooting for: laboratory instruments and computer hardware/software/network

* Supervised and trained laboratory analysts and performed data review and reporting* Validation of client/server chromatography system; developed test scripts and coordinated validation plan* Millennium Chromatography Data System (CDS) application administrator and trainer* Laboratory instrument troubleshooting and maintenance* Analytical testing utilizing HPLC, GC, FTIR, NMR, IR, and UV-Vis