OBJECTIVE:

• To use my skills, education and experience as a technical professional to provide the organization top quality service, whether as a temporary, contract or permanent employee.

TECHNICAL SKILLS:

Regulatory: comprehend and apply federal, local and institutional regulations, standards, and policies; training in EPA, DOT, DOE, FDA, ISO regulations; QA/QC, cGMP, GDP, GLP; USP, PCAB; comfortable in highly regulated environment; very detail - oriented with reading, writing and reviewing SOPs, batch records, equipment manuals, protocols, experiment and test plans, logbooks, data sheets, laboratory notebooks, Non Conformance Reports, CAPAs, investigations.

Health and safety: use of PPE including full-face APR/SAR; extensive OSHA training, first aid, CPR, spill response; researched, evaluated, set up and maintained new PPE program for department (at Sanofi-Synthelabo) and assisted health and safety department to train employees on program, and performed safety evaluations on all department equipment.

General laboratory: precision weighing, measuring, pipetting, mixing, glassware and instrumentation care and cleaning, etc.

Instrumentation and Equipment: Conductivity, pH, temperature, turbidity, UV-VIS spectrophotometry, TOC, gel electrophoresis Particle counter, rotary air viable sampler, bench top reaction vessels, centrifuges, filter housings, sonicators, water baths, pumps, mixers, etc.Pilot/R&D scale autoclave, chemical sterilizer, depyrogenation oven, stopper and vial washer, vial filling and sealing machine, lyophilizer, bottle sealers, tablet counters, tablet presses, encapsulators, mixers, granulators, fluid bed dryers, spray dryer, dedusters, inspection machine, tablet coater, sonicator, parts washer, reaction vessels, microfluidizer, centrifuge, jacketed tanks, filters, pumps, mixers, etc; production scale automated vial filling, sealing and washing machines, lyophilizers, compounding vessels, microfluidizer, incubators.

Waste management: RCRA hazardous, radioactive and industrial characterization, handling, packaging, storage, labeling, inspection; Hazardous Material Packaging and Transport; Envirostat 32 hour Sampling for Defensible Environmental Decisions class; storage and disposal site Waste Acceptance Criteria; 40 hour HAZWOPER; biohazardous material; proper treatment, disposal and decontamination procedures.

Software: Microsoft Office Suite, SAP, Trackwise QTS, JDE E1 and AS400, EPIcenter, CDR, PCCA Compounder, ComplianceWire, Summit, Workday

Other: critical cleaning and sanitization; aseptic technique; ability to perform experiments independently as well as function effectively on small teams and in large groups; ability to troubleshoot and problem solve; intermediate Spanish language skills; excellent interpersonal skills and ability to form effective relationships with team members and personnel from other departments and outside the organization.

PROFESSIONAL EXPERIENCE:

Confidential, Monument, CO

Inspector

Responsibilities:

• Member of Quality Department at orthopedic medical device manufacturer
• Review Device History Records for GMP/GDP/regulatory/procedural compliance, accuracy, completeness prior to lot release to ensure product quality and patient safety
• Perform lot release per ERP software (JDE AS400) procedures
• Part of primary DHR group interfacing with site corporate standardization team (JJOS) to create new detailed Work Instructions (JBS)
• Assisted in creation of new DHR production tracking (TAKT) board/spreadsheet

Confidential, Englewood, CO

Quality Control Technician 3

Responsibilities:

• Part of team to build Quality system for compounding pharmacy newly registered with FDA:
• 21CFR and 503B regulatory and cGMP compliance; USP, PCAB, Colorado State Board.
• Primary area of responsibility Non-Sterile Compounding Laboratory: SOP revision, process improvement/validation, employee training/validation, sample management, BUD studies.
• Sterile Department support: environmental monitoring/microbiology, sample management assist.
• Customer complaints; investigations; GDP training; equipment/calibration program

Confidential, Albuquerque, NM

Quality Services Technician IV

Responsibilities:

• Sample Item Portion: disassemble surgical instrument samples per SOP in laminar flow clean room environment for submission to contract lab for bioburden and sterility testing
• Monitoring of packaging Controlled Manufacturing Environment: total particulate, airborne and surface viable particulate, differential pressure; including media incubation and colony counting.
• Wrote SOPs for new Continuous Environmental Monitoring System, portable particle counter.
• SIP process labeling, packaging; sample request/shipping paperwork, spreadsheets, review forms
• Environmental monitoring: Rodac plates, TSA strips, Rotary Centrifugal Samplers, laser particulate counters, data entry forms, spreadsheets
• Overhead inventory and supplies; biological indicators prep; certified trainer

Confidential, Los Alamos, NM

Waste Management Coordinator

Responsibilities:

• Tech Area 21, Material Disposal Area B remediation project, Los Alamos National Laboratory.
• Managed Waste Container Storage Areas; radioactive, RCRA hazardous, industrial waste; regulatory compliance including proper labeling, signage, container integrity; inventory
• Coordinated shipping operations including correct container retrieval and verification, placarding and correct disposal site verification.
• Waste characterization; container inspection and preparation; supplies ordering.

Confidential, Lakewood, CO

Teaching Assistant/Lab Technician

Responsibilities:

• Assist instructor and lead students in Biology 111 laboratory exercises and ensure all equipment and supplies are set up for experiments; generate and proctor laboratory exams; assist chemical stockroom personnel as needed: washing, media and reagent prep, etc.

Confidential, Albuquerque, NM

Operations Technician

Responsibilities:

• Sterile vial, ampoule filling, sealing, Class 100 clean room conditions, GMP production facility.
• Loaded and unloaded product from lyophilizers.
• Checked and maintained filling and sealing process tolerances.
• Assisted in compounding operations.
• Assisted in development and scale-up of new processes including micro-sphere production, proprietary sterile lipid compounding and powder filling.
• Inspected vials for defects prior to processing.

Confidential, Albuquerque, NM

Pilot Plant Technician

Responsibilities:

• Prep, sterilize, clean critical equipment, components in pilot-scale GMP processing facility.
• Performed sterile vial filling and sealing under Class 100 clean room conditions.
• Checked and maintained filling and sealing process tolerances.
• Worked on team developing and optimizing proprietary sterile lipid compounding process.
• Loaded, unloaded, cleaned and operated lyophilizer.
• Maintained overhead supplies, parts and equipment inventory.
• Assisted formulations scientists and training of new personnel.
• Assisted review and writing of SOPs.
• First two months worked in Stability Department maintaining samples at various test conditions.