Microbiology Expert Resume

SUMMARY

Microbial Testing & Analysis - Microbiology Lab Design & Start-up - Quality Systems - Compliance
Protocol Development - SOPs - Action & Alert Levels - Method Development & Validation - Audits
Microbiological Control Analysis - Lab Equipment Management - Supply Ordering - Vendor Relations

Hardworking, proactive professional with a track record in microbiological testing, method validation, and chemical analysis. Thorough background in laboratory procedures and manufacturing.
Experienced in lab design, construction, and implementation. TEMPEffective leadership abilities with skills in training employees at all levels. Successfully planned and started a micro lab for Sentry Manufacturing. Met the challenges of MHRA and FDA audit, demonstrating test to FDA inspector.
Solid proficiency in cGMP, USP, EP, and BP guidelines. Self - directed working style with outstanding organizational and leadership abilities. Impeccable attention to detail. Skilled in SAP, MS Office, and lab automation software. Open to travel and relocation.

PROFESSIONAL EXPERIENCE

Confidential, Skokie, IL

Microbiology Expert

Responsibilities:

Spearheaded routine and non-routine analysis of raw materials and in-process and finished products. Oversaw implementation, documentation, and assessment of all microbiological control according to SOP and GMP. Drove microbiological analysis of products to ensure stability. Updated and executed SOPs. Synthesized data for test procedure documentation which included microbiological assays, stability program testing, and formulation studies.
Generated deviation document and change reports (CCR). Performed calibration and monitoring of lab equipment. Documented and assessed all microbiological control analyses.
Orchestrated investigations and drafted summaries and reports. Evaluated data obtained for compliance and identified report abnormalities. Planned and executed special projects. Addressed and resolved instrument problems. Managed ordering and checking of cultivation media and other consumables.
Coordinated investigation process media (e.g., nitrogen, compressed air, pure steam). Implemented release LALs and testing interim product stages for overall bacteria count. Handled environmental monitoring, investigated disinfecting agents, and performed trend analyses and assessments. Authored quarterly and annual reports and participated in MF simulation.

Confidential, Miami, FL

Responsibilities:

Successfully built a microbiology laboratory from the ground up to support solid and liquid dosage manufacturing units.
Devised methods and method validation in compliance with USP and EP requirements.
Supervised and trained employees.

Confidential

Responsibilities:

Authorized and implemented protocol for evaluation of the sterilization cycle for autoclaving bacteriological media.
Gained expert skills in investigation of OOS and other deviations, writing investigation reports, impact analysis, assigning root cause, and determining corrective and preventive actions (CAPA).
Lowered testing costs and achieved higher efficiencies within the lab.

Confidential, Miramar, FL

Microbiologist

Responsibilities:

Successfully identified microbial isolates from various sources by conventional, automatic system (Vitec II).
Oversaw and trained technicians and scientists.
Originated new methods.

Confidential, Largo, FL

Corporate Microbiologist

Responsibilities:

Introduced action and alert limits for environmental monitoring program in a manufacturing facility.
Crafted methods and method validation in compliance with USP, EP, and HPFBI requirements.
Managed audits conducted by the FDA and other agencies.

Confidential, Zephyrhills, FL

Quality Control Technician / Microbiologist

Responsibilities:

Significantly contributed to optimizing process establishment from batch filling to continuous production.
Managed and presented training to employees including educating new hires on QA testing.
Assured successful audits by the FDA and other agencies.