Selected Achievements:
- Within three months at Hyaluron, I developed, implemented and coordinated the Raw Material Test Program independently with management guidance. This included review of specifications and test methods per USP and EP Pharmacopeias, ordering necessary reagents and supplies and coordinating internal and external testing. I coordinated sampling, paperwork, storage and shipment of samples. I compiled, completed and reviewed the paperwork prior to submission to QA.
- At USBio, I standardized QC and Manufacturing operating procedures by creating interactive Excel spread sheets. These spread sheets enabled staff to enter data and interpret results independent of supervision. This process simplified calculation process and significantly reduced hours spent on assessment of results (~75%).
- Within three months of being Aseptic Cleaning supervisor at Baxter, I resolved an FDA citation by implementing a process that sterile filtered cleaning solution into the Aseptic Processing areas. To resolve this citation, I consulted experts, clean room supply vendors and companies with clean room environments. I coordinated activities with various in-house departments (i.e. Filling, Preparations, Engineers, QC Chemistry, Microbiology, etc). With minimal management direction, this project was completed on time, and met regulated guidelines and practices.
PROFESSIONAL EXPERIENCE:
QC Chemist
Hyaluron, Inc.
Burlington, MA
November 12, 2007 – May 30, 2008
- Achievement: Within three months at Hyaluron, I developed, implemented and coordinated the Raw Material Test Program independently utilizing management guidance. This included review of specifications and test methods per USP and EP Pharmacopeias, ordering necessary reagents and supplies and coordinating internal and external testing. I coordinated sampling, paperwork, storage and shipment of samples. I compiled, completed and reviewed the paperwork prior to submission to QA.
- Implemented and coordinated Raw Material sampling and testing process.
- Performed analytical chemistry tests on raw materials, in-process, finished formulations, and engineering projects samples.
- Performed general laboratory equipment maintenance and calibration.
- Reviewed QC data for accuracy, traceability and completeness.
- Initiated a QC Records Management System.
- Assisted with organization and maintenance of a functioning research laboratory.
Research Associate, Cell Culture / Bioassay Group
TGA Sciences (contract)
Medford, MA
May 21, 2007 – September 18, 2007
- Achievement: Independently investigated, created, and was in the process of developing a T-cell Hybridoma that would express surface IL-2.
- Independently and assisted with Investigation, creation, and development of methods for projects (cell culture, bioassays, ELISAs, and flow cytometry).
- Participate in the preparation of technical reports, summaries, protocols, and quantitative analyses.
- Assisted with organization and maintenance of a functioning research laboratory.
Technical Writer, Quality Assurance Assistant
Pharmasol Corporation (contract)
South Easton, MA
April 5, 2006 – February 23, 2007
- Technical writing of Protocols and Reports: Equipment IQ/ OQ/ PQ, Process Validation, Product Stability Studies, Annual Product Reviews, SOPs, forms, etc.
- Database Entry: NCMR, CAR, Deviations, and Training.
- Organization of Product Batch Records for Document Control and QC.
- Distribution of Controlled Documents.
- Maintenance of Controlled Document Binders.
- Assistance with QA and Compliance projects.
Customer Technical Support, 2003 - 2005
Supervision, Quality Control, 2003 - 2004
United States Biological
Marblehead, MA
April, 2003 – October, 2005
Customer Technical Support:
- Provided technical support to customers and staff regarding products listed in USBio's catalog/ website by researching the Internet and inquiring with the vendor.
- Resolved technical issues with products.
- Provided guidance and training as needed to staff with Mac File Maker Pro formatting and data base management/ usage.
- Revised product records.
- Added new products to meet customer needs.
Supervision, Quality Control:
- Achievement: At USBio, I standardized QC and Manufacturing operating procedures by creating interactive Excel spread sheets. These spread sheets enabled staff to enter data and interpret results independent of supervision. This process simplified calculation process and significantly reduced hours spent on assessment of results (~75%).
- Trained, mentored and coordinated QA/QC personnel (3-5). Assisted QC personnel as needed to ensure timely service.
- Performed administrative tasks: Interviewed potential candidates for QC and Tech Support. Wrote performance reviews. Reviewed QC Test documents for accuracy and completion.
- Established Bioburden, Endotoxin and Environmental Monitoring of manufactured media.
- Established organization and maintenance of a functioning laboratory. Established annual repair and maintenance of lab and manufacturing equipment. Established equipment monitoring logs. Investigated and ordered QC Lab and Manufacturing supplies and equipment.
- Created and revised SOPs for QC and Manufacturing. Reformatted and revised QC tests (i.e. Growth and Inhibition of Growth assays), Media Manufacturing Spread Sheet and Media Component Spread Sheet to reflect current practices and to be interactive in Excel.
- Calculated component mass for Media Manufacturing Spread Sheets.
- Issued QC Tests for raw materials and finished product testing.
- Established Manufacturing and Packaging Clean Room practices.
- Established EHS practices and procedures. Established Respirator fit, use, maintenance practices.
- Maintained MSDS data base.
- Contracted disposed of hazardous waste.
- Contributed to Supplier Audit Questionnaires and Supplier Site Visits.
Supervision, Gnotobiotic and Animal Production
Taconic West Coast Operations
Oxnard, CA
July, 2001 – July, 2002
- Trained, mentored and coordinated Animal Caretaker personnel (5-7). Coordinated equipment and breeding programs for various mouse colonies in Gnotobiotic and Production areas. Assisted Animal Caretakers as needed to ensure timely service.
- Ensured compliance with Standard Operating Procedures, safety regulations and company policies.
- Performed administrative tasks: Interviewed potential candidates for Animal Caretaker. Wrote performance reviews. Reviewed and approved time cards. Reviewed production reports and other documents.
Validation Assistant
Alpha Therapeutic Corporation (contract)
Los Angeles, CA
February – May, 2001
- Performed administrative tasks: Reviewed data entry. Reviewed time cards for Project Time.
- Assisted with writing, reviewing and executing process validation protocols.
Supervision, Aseptic Cleaning, July, 1997 – August, 2000
Quality Control Analyst A, Immunology Laboratory, November, 1994 – July, 1997
Research Associate, Blood Replacement Products (contract), May, 1993 – May, 1994
Baxter Healthcare Corporation
Los Angeles, CA
May, 1993 – August, 2000
Supervision, Aseptic Cleaning:
- Achievement: Within three months of being Aseptic Cleaning supervisor at Baxter, I resolved an FDA citation by implementing a process that sterile filtered cleaning solution into the Aseptic Processing areas. To resolve this citation, I consulted experts, clean room supply vendors and companies with clean room environments. I coordinated activities with various in-house departments (i.e. Filling, Preparations, Engineers, QC Chemistry, Microbiology, etc). With minimal management direction, this project was completed on time, and met regulated guidelines and practices.
- Trained, mentored and coordinated Aseptic Cleaning personnel (8-12). Coordinated the cleaning/sanitization of the Aseptic Processing areas. Planned and directed special cleaning projects/request. Assisted Aseptic Cleaning personnel as needed to endure timely service.# Trained, mentored and coordinated Aseptic Cleaning personnel (8-12). Coordinated the cleaning/sanitization of the Aseptic Processing areas. Planned and directed special cleaning projects/request. Assisted Aseptic Cleaning personnel as needed to endure timely service.
- Ensured compliance with SOPs, Regulatory, and EHS.
- Established annual Core Competency written and demonstration testing based onSOPs for Aseptic Cleaning department.
- Maintained SOP binders and QA issued forms for Aseptic Cleaning and Filling Department.
- Investigated and ordered Clean Room maintenance equipment and supplies.
Quality
Control Analyst A, Immunology Laboratory:
- Achievement: I developed a process to suspend human plasma
paste to perform raw material testing and engineering studies.Performed raw
material, product in-process and final container testing.
- Performed routine
assays (i.e. LAL, RID, IEP, ELISA and Ouchterlongy).
- Performed non-routine
assays (Paste suspension and testing for LAL, Plasminogen ELISA).
- EHS
representative. Maintained MSDS files. Presented seminar on Hazard Material
Identification System (HMIS) and understanding of MSDS to all QC Lab personnel.
- Disposed
of hazardous and biohazardous wastes.
- Assisted with organization and maintenance
of a functioning research laboratory.
Research
Associate (contract):
- Developed and validated ELISAs to detect anti-mouse,
anti-CHO, and anti-bovine antibodies in clinical samples from patients treated
with recombinant Factor VIII.
- Performed various Coagulation Factor analyses on
engineering study samples of blood replacement products.
- Assisted with organization and maintenance of a
functioning research laboratory.
Research Associate
Vaccine based therapeutics to treat autoimmune disorders
Medclone
Los Angeles, CA
June – September, 1994
- Developed and validated ELISAs to detect anti-idiotypic antibodies.
- Assisted with organization and maintenance of a functioning research laboratory.
Research Associate
DNA oligonucleotide and protein synthesis, Minnie McMillan, Ph.D.,
USC Health Science Campus
Los Angeles, CAMay, 1992 – May, 1993
- Performed automated DNA oligonucleotide and protein synthesis and purification.
- Maintained instruments.Assisted with organization and maintenance of a functioning research laboratory.
Research Associate
Arteriolosclerosis and Lipids, Michael C. Schotz, Ph.D., August, 1991 – February, 1992.
Immune Cell Regulation, John L. Fahey, M.D., October, 1990 – May, 1991.
UCLA/Wadsworth VAMC
Los Angeles, CAOctober, 1990 – February, 1992
Arteriolosclerosis and Lipids, Michael C. Schotz, Ph.D., 1991 – 1992:
- Maintained and performed mutations, transformations and transfections on microbiological cultures.
- Performed polyclonal antibody production, purification and characterization.
- Performed HDL and LDL analyses on clinical and research samples.
- Performed basis Microbiology and Molecular Biology assays (i.e. SDS-PAGE, Western, Northern and Southern Gel Electrophoresis, Transblotting, Immunoblotting, Immunoprecipitation, PCR, DNA and RNA isolation).
- Performed animal husbandry: Chickens and mice.
- Assisted with organization and maintenance of a functioning research laboratory.
- Monitored for radiation contamination. Disposed of hazardous and biohazardous wastes.
Immune Cell Regulation, John L. Fahey, M.D., 1990 – 1991:
- Maintained and performed mutations, transformations and transfections on tissue and cell cultures.
- Performed human lymphocyte isolation.
- Developed and validated RIAs.
- Performed administrative tasks: Performed and reviewed data entry. Ordered Supplies. Monitored budgets.
- Assisted with organization and maintenance of a functioning research laboratory.
- Monitored for radiation contamination. Disposed of hazardous and biohazardous wastes.
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