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Quality Control Microsoft Office

Location:
Atlanta, GA
Salary:
55000
Posted:
March 16, 2017

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Resume:

Samuel E. Scott Jr.

**** ******* **** **** *-**

Atlanta, GA 30331

aczbzu@r.postjobfree.com

919-***-****

Education

North Carolina State University

College of Agriculture and Life Sciences

****-*008

B.S., Microbiology

B.S., Plant Biology

Post Baccalaureate Studies in graduate level

Genetics, Functional Genomics, Food Microbiology, Plant Biology, and Mycology

Professional Experience

Valeant Pharmaceuticals

Immunotherapy Manufacturing facility, Union City, GA

August 2015-present

Quality Control Specialist – Microbiology (3rd Shift)

Performs routine environmental monitoring, including air viable (SAS) particulate, viable surface sampling in ISO/5 areas specifically Biological Safety Cabinets (BSCs) while using proper aseptic technique.

Performs assays for qualifying raw materials and for release or stability testing of in-process and finished products. These test methods include endotoxin, complete blood count, viability, gram stain, growth promotion, and sterility and Bac T.

Write trending reports and checking reviewing lot folders for QA submission

Initiates and takes ownership as needed of miscellaneous laboratory projects and related assignments.

Performs routine laboratory equipment maintenance such as plate reads and enumeration of bacteria and write trending reports on Alert and Action levels.

Able to gown in aseptic and clean room environments

Performs aseptic gowning qualifications for manufacturing and other staff

Revises and updates standard operating procedures.

Performs testing in support of method validation studies.

Adheres to good documentation practices to ensure data integrity and traceability.

Uses professional concepts and company policies and procedures to solve a variety of problems.

Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action.

Normally receives general instructions on routine work, detailed instructions on new assignments.

Experience with LIMS and other documentation software for receiving, monitoring and tracing samples.

Serve as principal investigator on sterility OOS investigations

Perform gowning qualifications for manufacturing and QA staff

Assists with equipment repair and validation

Assists with the training and development of analysts and lab personnel

Maintained cGMP and GLP compliance and documentation

Pfizer/Hospira Pharmaceuticals

Rocky Mount Plant

November 2013-July 2015

Biological Quality Laboratory Analyst I - Environmental Microbiology (3rd Shift)

●Collect and process samples in a timely manner, review laboratory assay documentation for accuracy and timeliness, evaluate preliminary results; aids in the development of test methods and participate with the team to meet group goals and perform routine laboratory duties.

●Perform Water, Steam, and Critical Utility collection as well as associated testing.

●Perform Environmental Monitoring in ISO 5, 7, 8 areas

●Perform Bioburden Testing of In-Process products, buffers, and water.

●Receive manufacturing samples into the QC Lab as well as sample retain disposal.

●Troubleshoot assay and instrument problems with Laboratory Supervisor.

●Enter and review data in LIMS (i.e. Sample Manager)

●Perform safety and operational lab audit.

●Perform general maintenance of lab equipment.

●Participate in writing and revisions SOPs, protocols.

●Assist in the development and optimization of testing methods.

●Maintain log books related to inventory and equipment.

●Ensure labs are clean and safe (in compliance with cGMP) and properly stocked.

●Make detailed observations in support of Alert, Action, and OOS result investigations (i.e. CPMS system)

●Participate in the qualification of equipment, methods, and processes.

●Participate and perform special studies & projects assigned to microbiology.

●Perform plate reading, gram staining, microbial identification.

●Perform routine Quality Control testing of in-process and final products in a cGMP lab for release.

●Perform other additional job related duties as required.

●Maintained cGMP and GLP compliance and documentation

Syngenta Biotechnology

September 2012-January 2013

Assistant Scientist, Molecular Analytics and Stewardship and Quality Control (SQC)

Accountabilities

●Responsible for extracting genomic DNA from biological material using molecular biological techniques

●Used laboratory automation and robotics for extracting genomic material

●Prepared and mixed reagents and chemicals for experiments

●Cleaned and maintained laboratory equipment used in research efforts

●Recorded and entered data in laboratory notebook and spreadsheets

●Worked independently as part of a global team

●Trained in Stewardship and Quality control

●Followed written biological protocols relative to experiments

●Used electronic pipettes for aliquoting samples for PCR analysis

●Centrifugation equipment

●Milling of samples using using electrical grinding equipment

●Sample preparation and packaging

●Maintained clean work areas

●Experience with 384 well qPCR experiments and computer equipment (SDS software)

●Maintained communication with senior scientists and lead scientists

●Used Microsoft Office specifically Excel spreadsheet

●Working knowledge of the use of standard laboratory equipment (thermal blocks and thermal cyclers)

Medicago, USA, GMP Facility

July 2011-August 2012

Biotech Process Specialist I, Greenhouse/Laboratory division

Accountabilities

●Extracted proteins from biological material for biochemical and quantitative analysis in the production of vaccines

●Assisted with agrobacterium-mediated transformation of biological material

●Performed all microbiological testing on samples in the laboratory according to protocols, SOPs and Work instructions (i.e. gram staining)

●Wrote and revised standard operating procedures and work instructions for vaccine production

●Assisted in the development and revision of batch records

●Performed cleaning and maintenance of laboratory equipment

●Performed dilutions for preparation of media and molecular biological techniques

●Used sterilization equipment for biohazard biological material such as autoclave and Steris cleaning equipment

●Prepared media for research experiments

●Used electronic devices to measure pH, electrical conductivity of samples

●Washed and cleaned glassware using electric dishwashing equipment

●Assisted with the order of supplies and research equipment needed for research projects

●Performed experiments using biochemical assays (i.e. hemagluttanin assay)

● Knowledge of laboratory safety and infection control procedures and practices including standard precautions and hazardous chemical handling.

● Strong technical knowledge of complex testing procedures and the science supporting the analysis.

●Proficiency with more complex laboratory calculations regarding batches and specimens including averages, means, standard deviations, and various quality control metrics.

●Recorded and entered data in laboratory notebooks and spreadsheets

●Performed experiments in 96 well format

●Use of thermal blocks, homogenizers

●Used robotic equipment in support of vaccine production

●Petri plate monitoring and preparation

●Maintained clean work areas

●Used Microsoft Office software specifically Excel, Outlook and Powerpoint

●Communicated with scientists in reference to research findings and analysing results

●Supervised contract and temporary employees

Certifications/Training

Good Manufacturing Practices (cGMPs)

Good Laboratory Practices (GLPs)

Gram Staining

Plate preparation and monitoring

Preparation of inoculum and growth media

Environmental monitoring

Bacterial sample culture in incubators and growth chambers

Bacterial cell enumeration

Microscope use

Membrane filtration method

Biomanufacturing training

Western Blot

Able to use a forklift and other basic transfer devices

Used weights and scales to measure biological material

Centrifugation

N.C. State University, Department of Molecular and Structural Biochemistry

September 2002-October 2004

Laboratory Assistant

Accountabilities

●Washing and cleaning glassware using dishwashing equipment

●laboratory equipment up keep and maintenance

●Autoclaving biohazard materials

●Maintained a laboratory notebook

●Performed DNA extraction/HPLC assays for sample analysis

●Mixing reagents and making dilutions

●Assist with laboratory experiment set ups

●Performed gel electrophoresis based experiments

●Maintained clean work area

●Assisted with ordering and maintaining laboratory supplies

●Reported problems and issues to Laboratory Manager

●Followed all safety instructions and procedures

●Attended laboratory meetings and gave suggestions on laboratory improvement

Cornell University, Department of Microbiology

May 2002-August 2002

Howard Hughes Summer Research Fellow

Project: Finding light induced genes in Phytochrome using Agrobacterium tumefaciens

Principal Investigator: Stephen Winans

Graduate Mentor: Anja Brencic

●Inoculating agar plates

●Used a pipette aseptically

●Use hoods for inoculating and working with bacteria

●preparing growth media

●enumerating bacteria; plate counts

●bacterial mutagenesis

●bacterial transformation

●microscope usage

●Washing and cleaning glassware using dishwashers

Essential Job Skills

Ability to work in fast paced and different adverse environments (hot, cold, windy etc.)

Self Starter; start-up company experience

Worked in Clean Room laboratories

Microsoft Office (Word, Powerpoint, Excel, Outlook)

LIMS

Ability to gown aseptically in clean rooms

Donned PPE for biomanufacturing activities

Able to work multiple/alternate shifts

Strong team orientation; adaptability; versatility and curiosity

Energetic, good work ethic and dependable

Effective communication, observation and prioritization skills

4 years GMP training

5+ years GLP training

Supervisory Experience

1.5 years, Medicago, USA

Volunteer Activities

Collegiate 100-Secretary and Treasurer 2007-present

●Mentor and assist high school youth about post high school and college opportunities

●Responsible for all monetary and budgeting responsibilities

●Reports to President of organization progress and suggestions

●Assist in the selection of future candidates to the organization such as interviewing and other recruiting events

Guest Judge at Meredith College Science Competition 2007 and 2008

Awards and Honors

Phi Kappa Phi Honors Society

National Society of Collegiate Scholars

Leadership Alliance Summer Research Fellow, Cornell University

Research Experience for Undergraduate Summer Fellow at N.C. State University

Emerging Leaders Program Participant, N.C. Wesleyan College

Judge at 2007 and 2008 Science Fair at Meredith College

Golden Key Honors Society

100 Black Men of America

Tuition Scholarship (valued at 1,500/yr)

Caldwell Fellows Scholarship program finalist

CALS Honors Program

References

Matt Timothy Smith

Biological Quality Supervisor

Hospira Pharmaceuticals

Mobile: 919-***-****

Frederick Okech

Sr. Quality Control Associate I

Valeant Pharmaceuticals

Mobile: 845-***-****



Contact this candidate