microbiologist
Resume:
Carmen C. Schulz
Ft Worth, TX
***.*******@*****.***
LinkedIn.com/in/Carmen-c-Schulz-7b67a215a
Scientist / Quality Assurance Analyst
Bilingual Research Scientist and Quality Assurance Analyst with extensive experience conducting analytical testing in Quality Assurance and Research Development Microbiology within the pharmaceutical industry.
Proficient in analyzing experimental data, processing and approving results for manufacturing production and research batches under constrained manufacturing production and research project deadlines.
Highly effective in collaborating with manufacturing and research project leads, managers and cross functional groups to ensure optimum release of deliverables impacting manufacturing production and research/development batches.
Skills include:
•Analytical microbiological compendial and method development/validation testing: endotoxin, sterility, preservative efficacy and bioburden testing
•Equipment validation/requalification testing
•Equipment calibration and maintenance
•Environmental monitoring sampling and testing for both clean rooms and La Calhene barrier isolators
•Media fills/reactor holds laboratory logistics
•Biological indicators receipt, maintenance and testing
•Maintenance of stock cultures and preparation and use of bacterial/ fungal suspensions
•Inventory and qualification of media for laboratory use
•Gamma Dose Audit testing
•Milliflex sterility rapid method
•Compendial and other regulatory requirements interpretation and implementation
Professional Experience
ALCON LABORATORIES, INC., Fort Worth, TX June 1989 February 2018
Scientist (May 2008 - February 2018)
Oversaw and executed all aspects of membrane filtration and direct sterility testing method development, bacteriostasis/fungistasis and routine release testing and LaCalhene barrier isolators maintenance.
Developed, originated and executed protocol activities for the approval of validation/requalification of LaCalhene barrier isolators.
Oversaw and executed receipt, maintenance and testing of biological indicators.
Oversaw and executed microbiological testing for the release of reactor holds samples and media filled units in support of research process development activities.
Performed endotoxin, preservative efficacy and bioburden testing in support to primary scientist.
Oversaw inventory, preparation and use of commercial bacterial/fungal suspensions and stock cultures.
Oversaw all aspects of inventory and qualification of laboratory media by performing quality checks / GPQ testing for laboratory use release.
Oversaw monthly calibration of spiral platter.
•Efficiently performed sterility testing method development, validation and routine release testing for developmental, nonclinical, clinical and stability research batches as well as biological indicators and ampoules for validation sterilization runs to meet project, qualification and requalification deadlines.
•Effectively created, executed and provided data for approval of validation/requalification activities for LaCalhene barrier isolators for both peracetic acid and VHP cycles, as well as weekly, monthly, quarterly and annual maintenance activities ensuring support of routine release testing.
•Effectively and promptly performed sterility confirmation and growth promotion testing for reactor holds samples and media filled units in support of validation and requalification activities of process development processes.
ALCON LABORATORIES, INC., Fort Worth, TX
Quality Assurance Analyst ( June 1989 - May 2008)
Performed analytical testing in the following areas: endotoxin testing (gel clot, turbidimetric and chromogenic methods); gamma dose audit testing; media fills; preservative efficacy testing; sterility testing; bioburden testing ; biological indicators qualification and sterility confirmation testing and environmental sampling and testing.
Performed sampling of PW, WFI, steam and non-viable particulates.
Prepared technical validation documents and executed functional testing for equipment validation and requalification ( e.g. depyrogenation oven, Endoscan).
•Efficiently performed analytical testing in support of release of manufacturing production batches.
•Efficiently oversaw all aspects of incubation, sterility assurance and growth promotion testing for reactor holds and media filled units towards support of requalification of manufacturing production lines.
EDUCATION
Bachelor of Science, Microbiology,
Texas A&M University, College Station, TX
Biology and Pre-Med Courses
Texas Christian University, Fort Worth, TX
Fluent in both English and Spanish
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