Gregory Powell Greater Los Angeles Area

Company Name

Baxter Healthcare (Pharmaceuticals)

Position Held

Quality Control Analyst II Bacteriology

Dates

0000 - Present

Details

• Performed isolate identification using Gram Stain, Vitek, Biolog, and Supplemental Assays to determine root cause of contamination and preventative action measures
• Qualified in receiving, contamination check, growth promotion, and release of media/reagents with superior attention to detail and consistently delivering desired results
• Skilled at Microbial Limit Testing (MLT) according to USP guidelines
• Proficient in testing biological indicators to assist in sterilization cycle development and process validation
• Analyzed and executed validation protocols for sterility testing for new products and researching harmonizing of MLT methods
• Appointed as project manager for Monthly and Quarterly Trending project which includes supervising six team members, compiling data, and presenting findings to other departments

Company Name

Baxter Healthcare (Pharmaceuticals)

Position Held

Quality Laboratory Associate II Environmental Monitoring

Dates

0000 - Present

Details

• Adept at environmental monitoring in ISO Class 5, 7, and 8 of surfaces, viable and non-viable air, settling plates, utility systems, compressed gas, liquid particulate, and personnel
• Skilled at In Process Bioburden testing and Sterility Testing
• Served as adjunct lead on weekends performing duties such as scheduling daily tasks, ensuring department runs smoothly, and solving problems as they arise.
• Qualified in laboratory duties such as preparing equipment, operating autoclave, pipette calibration, Kaye system laboratory watch, and visual inspection of growth media
• Issued and completed Laboratory Investigation Reports, Change Requests, and Non-Conformance Reports
• Chosen to spearhead startup and commissioning of manufacturing suites which included organizing employees, coordinating with other departments, recording results, disseminating information and completing project by the deadline set forth
• Audited personnel in aseptic practices and performed gown certification/recertification
• Trained and mentored team members in accordance with Good Aseptic Practices, Good Laboratory Practices, and Standard Operating Procedures

Company Name

Baxter Healthcare (Pharmaceuticals)

Position Held

Manufacturing Associate I Formulation and Finishing

Dates

0000 - Present

Details

• Skilled in the manufacturing process and technique of recombinant Factor VIII
• Certified in aseptic clean room procedure and gown/media fill qualified
• Performed component preparation by utilizing autoclave, vial washer, vial tunnel sterilizer, and stopper sterilizer
• Formulated and sterile-filtrated Isopropyl Alcohol and performed filter integrity testing
• Completed, analyzed, and recorded manufacturing data
• Trained team members in accordance with Current Good Manufacturing Practices and Standard Operating Procedures