Kathleen Fox
Quality Control Analyst 1 at Polysciences, Inc.- Claim this Profile
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Experience
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Polysciences, Inc.
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United States
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Biotechnology Research
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100 - 200 Employee
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Quality Control Analyst 1
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Mar 2021 - Present
Perform Quality Control testing of raw materials, in-process, finished product, and stability samples per approved specifications and test methods. • Assist in sampling and testing of raw materials upon receipt, when needed. • Familiar with GMP documentation of results and assurance of laboratory data integrity; Experience with electronic data entry, i.e. ERP/LIMS system. • Experience with USP/EP interpretation and testing. • Support QC audit readiness with understanding of FDA and ISO regulations and requirements. • Support on-time performance in the Quality Control lab against the Production schedules. • Assist with maintenance and troubleshooting of QC lab equipment to minimize downtime. • Assist with OOS and NC/CAPA investigations. • Maintain a safe, clean, and organized environment (5S) for all QC areas. • Employ sound and compliant laboratory techniques and logic per industry standards (e.g., FDA, USP/NF, ISO, ANSI) and internal and customer requirements. • Keep Supervisor informed of any Quality related issues that arise in the laboratory.
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Avantor
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United States
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Biotechnology Research
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700 & Above Employee
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Laboratory Technician
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Oct 2019 - Mar 2021
To ensure safety, by working in accordance to all relevant Production and Environmental, Health & Safety procedures, promptly reporting any incidents or accidents to a manager • To undertake process operations under minimal supervision of a senior member of staff, in accordance with all relevant production procedures and process instructions • Follow process procedures diligently, and give feedback for process improvements • To prepare media/buffers in accordance with Avantor and Johnson & Johnson standards in a timely and efficient manner. • Communicate effectively with supervisors and colleagues, particularly supporting colleagues to cover workload during breaks and across shifts. • To keep track of inventory as it pertains to supplies for the laboratory and communicate information to appropriate team lead. • Ensure files and documents are recorded and filed in an accurate, timely manner without need of supervision.
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Tolmar
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Microbiology Laboratory Technician
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Sep 2018 - Aug 2019
Prepare solutions and reagents, media, components for sterilization. General laboratory record keeping and record storage. Performs general laboratory cleaning, assist with laboratory order and check-in of laboratory supplies, and perform quality controls. Maintains database microorganism reference cultures. Provide laboratory support such as maintain instrument use manuals and maintain general use forms and labels. Perform test procedures such as water testing, residual detergents testing, and pipette calibration. Perform test procedures such as water testing and sampling, components testing, environmental monitoring read and pipette calibration. Log in samples into laboratory tracking software. Enter Microbiology data into Microbiology trending system
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ADP
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United States
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Human Resources Services
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700 & Above Employee
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Sourcing Specialist
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2015 - 2018
Process automated and manual searches for criminal, civil and worker's compensation records. Answer data-related questions and conduct research as necessary. Monitor and correct order errors that prevent process continuation. Compile reports for client including/not limited to criminal history, civil lawsuits and education backgrounds. Research public records, process criminal and sex offender records on a county, state, and federal level. Process automated and manual searches for criminal, civil and worker's compensation records. Answer data-related questions and conduct research as necessary. Monitor and correct order errors that prevent process continuation. Compile reports for client including/not limited to criminal history, civil lawsuits and education backgrounds. Research public records, process criminal and sex offender records on a county, state, and federal level.
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Education
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Keystone College
Bachelor of Science - BS, Environmental Resource Management