Rocío R. Email & Phone Number

United States

Austin, Tx, Us

Austin, Tx, Us

- Managed design control for ISO 13485 and FDA 21 CFR Part 820-regulated projects from NPIs to obsolescence, successfully obsolescing 2 finished goods, qualifying 2 scaleups and market launching 2 finished goods- Drove CAPA progress as site CAPA coordinator, managing 6 CAPAs through all phases, and assisting in the SmartSolve integration from legacy hardcopy processes- Participated in 7 ISO, FDA, customer, and internal audits in multiple roles as lead, reviewer, scribe, and auditor- Lead cross-site monthly quality review for over 700 IVD and RUO reagent and assay product lines- Developed SOP training and questionnaires distributed via Oracle for global site training initiatives

Austin, Tx, Us

- Directed complaint investigations and evaluated non-conformities including SCARs, NCMRs, MNRs, and equipment incident reports (EIR)- Developed training on Agile ECO (engineering change order) review and trained incoming QA personnel- Supported manufacturing building move for sample-to-answer PCR systems enabling real-time testing forsamples including SARS-CoV-2, releasing 30+ deliverables to achieve quality plan completion

Trento, It

- Spearheaded quality department development for a contract manufacturer start up, creating QC, QA, and supplier quality programs and directing all laboratory operations and vendor contracts- Supervised quality technician team of up to 14 members and administered interdepartmental, cross-level training for 200+ employees to achieve qualification of 8 product lines- Executed NPI validations for a Nielsen Breakthrough Innovation Winner fabric scent booster generating over$150M in annual sales, successfully introducing 2 finished goods to the U.S. market- Enhanced IQC program to facilitate incoming raw material flow, reducing non-conformities and improving PR and release times by over 10% while maintaining department budget requirements

Ft. Worth, Tx, Us

- Executed microbiological testing for FDA-regulated nutritional, cosmetics, and OTC drugs manufacturer partnering with 5+ Fortune 500 companies.- Implemented growth promotion, suitability, and environmental monitoring programs within first year of hire. Authored and integrated internal laboratory environmental monitoring program.- Trained incoming technicians and interns on laboratory techniques and new SOPs.- Led antimicrobial efficacy and equipment validations in collaboration with validation department.

Tuscaloosa, Al, Us

Dr. Jennifer Edmonds – Center for Freshwater Studies• Investigated the role of dissolved organic matter in cave water biofilm communities utilizing fluorescence spectroscopy, Parallel Factor Analysis, and MATLAB

Tuscaloosa, Al, Us

Sarah Szurek, Ph.D. Candidate – Department of Anthropology• Interpreter for Ph.D. dissertation research investigating dietary trends in Latino communities"Cultural Models of Food and Social Networks Among Mexican Immigrants in the Southeast United States" (2011)