S.Christine Yoder Email & Phone Number

Auckland, New Zealand, Nz

Norwalk, Connecticut, Us

Responsibilities include initiate, investigate, perform root cause analysis, create and track CAPAs for non-conformance events including facilities, sterile fill production, chemistry, and microbiology events using Zen QMS system. Use Zen QMS system, Trackwise, and Veeva to review and approve process and document Change Control and initiate and approve work instructions, protocols, batch record revision, and raw material specification. Review and approve Validation and product stability protocols and reports. Use of SAP system to track product and raw materials. Use of Fiix system to review and approve preventative maintenance and calibration completion. Create and present biannual cGMP and GDP training. Review and respond to customer product complaints. Lead internal audits and assign resulting CAPAs. Observe and document sterile gowning and behavior during biannual sterile media fill and as required. DEA Coordinator tasks including host successful DEA Regulatory audit. Track and review DEA raw material purchases and product sales, ensuring no suspicious orders, review DEA access for appropriate staff, prepare and edit work instructions regarding handling and security of DEA raw materials and finished goods. Perform annual DEA inventory. Reconcile all DEA waste and lead redistribution with approved waste removal company. Review and approve site security tests for controlled substance security. Quality representative for Customer existing products and in-development products. Responsible for State and Federal manufacturing and controlled substance license initiation and renewals. Responsible for External Audit CAPA assignment and completion. Responsible for Quality Management Review meeting agenda and minutes.

Hayward, Ca, Us

Responsible for QMS systems including: Nonconformance and CAPA, Document control, Product/Process Change Control, Customer Complaints, Batch Record Approval and Release, Quality Management Reviews, assist in Internal Auditing. Successfully passed external audits in 2017 to ISO 14001:2015, ISO 13485:2016, ISO 9001:2015. Plastikon Healthcare provides custom blow molding and aseptic liquid fill contract manufacturing. Our one-step process uses follow the Current Good Manufacturing Practices (cGMP) per 21CFR 210-211 and Quality Management System per 21CFR-820.

Secaucus, Nj, Us

Responsibilities include writing QSR work instructions and performing QC of incoming IVD Medical Devices including oral fluids, urine and hair testing supplies. Stability testing design, data collection and documentation of existing and new products. Antibody testing and conjugate preparation for ELISA and EIA Homogeneous drug assays. Development of ELISA and EIA homogeneous drug assays. Writing QSR documents for calibration, maintenance, and validation of laboratory equipment. Writing of SDS safety documents for existing and new products. Performing research and documenting with formal reports for new and existing 510(k) drug assays. Design, perform and document development and troubleshooting of ELISA hair plate testing. Participating in interdepartmental project discussions and troubleshooting. Training of lab members in all aspects of documentation and execution of lab protocols. Responsible for maintaining inventory supply of lab consumables.

Responsibilities included ELISA design and validation per USDA APHIS 9CFR requirements, mammalian and bacterial cell culture, immunofluorescent assays, real-time PCR and DNA isolation. Trained and CDC-certified in BSL/3 protocols and lab safety. Trained in GLP and GMP requirements. Performed data and report QA for R and D department. Experiment design, implementation and report writing per government regulations. Responsible for communicating with department leaders and employees regarding ELISA development, data acquisition and government report submissions.

Lawrence, Ks, Us

Responsibilities included maintenance and genetic analysis of Drosophila melanogaster and Drosophila virilis for studies of small interfering RNAs. Designed and optimized extensive protocol for cloning and Illumina sequencing small interfering RNAs. Responsible for training undergraduate and graduate students within the lab. Developed and maintained professional working relationships within other labs in various departments to achieve equipment sharing and project assistance.

Responsibilities included preparation and verification of all internal and control standards for 13 different drug testing categories, preparation and verification of all laboratory solutions used for extraction and analyzing drug analytes. Chemical extraction of urine samples from outside vendors to verify analyte concentrations. Maintenance of gas chromatograph mass spectrometers. Generation and proper storage of all documents required for state and national drug inspection agencies. Preparation of mobile and aqueous phases for liquid chromatography mass spectrometers.

New York, New York, Us

Responsibilities included DNA vector design for animal vaccines, screening cDNA libraries, and lambda DNA isolation. Techniques used included: PCR, RT-PCR, viral DNA and RNA extraction, DNA plasmid preparations including transformation and RFLP analysis, DNA primer design and sequencing. Additional techniques included ELISA assays, Western blotting, SDS-PAGE, antibody production in rabbits, virus neutralization assays, tissue culture techniques including primary cell line production, viral inoculation of cells, transfections, cell counts and virus inactivation. Animal challenges and sample processing of bovine, canine and feline studies in accordance with IACUC protocols.

Omaha, Nebraska, Us

Research responsibilities included the following techniques: protein separation using polyacrylamide gel electrophoresis, Western blotting, silver staining, ELISA assays, several types of chromatography including affinity, ion exchange and gel filtration. Other techniques included isolation of proteins from human plasma and placenta, purification of IgG from ascites and maintenance of cell stocks using tissue culture techniques. Responsible for general lab maintenance including: preparation of lab stock solutions, ordering chemicals and lab equipment and conducting monthly radiation surveys. Responsible for training and supervising summer students.

Master Of Science (M.S.), Molecular Biology

Bachelor Of Science (B.S.), Biology

Education record