Robin S Bushnell Email & Phone Number

Responsible for quality assurance and regulatory compliance for the Ithaca ny site.

19 Brown Road Ithaca Ny14850

• Plan, schedule, conduct, report and close audit activities in any of the countries involved with Q2 Solutions/Quintiles contracts. Audits are conducted to assess compliance with applicable regulations/guidelines, customer requirements, Q2 Solutions/Quintiles SOPs and project specific guidelines/instructions• Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers• Provide interpretation and consultation to project teams on regulations,… Show more • Plan, schedule, conduct, report and close audit activities in any of the countries involved with Q2 Solutions/Quintiles contracts. Audits are conducted to assess compliance with applicable regulations/guidelines, customer requirements, Q2 Solutions/Quintiles SOPs and project specific guidelines/instructions• Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers• Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures• Provide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plans• Prepare and review and approve corrective action plans• Present educational programs and provide guidance to operational staff on compliance procedures• Conduct quality assurance consultancy activities and projects for clients within budget and established timelines• Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements• Host customer audits• Assist in hosting mock regulatory inspections and regulatory facility inspections by acting as scribe and/or reviewing documents and identifying and calling operational staff to answer questions as needed• Ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections• May perform GLP Archivist duties where needed• Assist in training of new Quality Assurance staff Show less

Ithaca, New York Area

Audit data, laboratory records, and reports for accuracy and compliance to SOPs, validation, regulatory, and customer requirements.

Responsible for coding and abstracting all Emergency Department Medical Records, support coding for OPR, Prompt Care, and some inpatient records

• Supervised directly and through subordinates 50 employees in Validation, Document Control, Quality Control Inspection, Compliance, Calibrations, Analytical, and Microbiology divisions that cover multiple shifts, 7 days per week• Coordinated all aspects of the QA Department for the Cortland, NY facilities regarding staffing, budgets, investigations, compliance to procedures and regulations, as well as creation of policies and implementation of process improvements• Directed support… Show more • Supervised directly and through subordinates 50 employees in Validation, Document Control, Quality Control Inspection, Compliance, Calibrations, Analytical, and Microbiology divisions that cover multiple shifts, 7 days per week• Coordinated all aspects of the QA Department for the Cortland, NY facilities regarding staffing, budgets, investigations, compliance to procedures and regulations, as well as creation of policies and implementation of process improvements• Directed support for Production Operation Personnel to ensure product quality, training, and process improvements • Worked with customers and Marietta personnel to problem solve and/or address complaints or quality issues on a daily basis• Communicated effectively, both verbally and in writing, with customers, sales, marketing, and operations to ensure product quality, meet regulatory compliance, and increase profitability• Led customer and regulatory audits Show less

• Supervised 5 to 22 employees in 3 QA/QC Labs spanning multiple shifts • Coordinated through subordinates all aspects of the QA/QC Labs in order to meet customer and regulatory requirements for testing and product release, including maintenance of laboratory procedures, systems, and calibration• Worked with customers and Marietta personnel to problem solve and/or address complaints or quality issues on a daily basis• Communicated effectively, both verbally and in writing… Show more • Supervised 5 to 22 employees in 3 QA/QC Labs spanning multiple shifts • Coordinated through subordinates all aspects of the QA/QC Labs in order to meet customer and regulatory requirements for testing and product release, including maintenance of laboratory procedures, systems, and calibration• Worked with customers and Marietta personnel to problem solve and/or address complaints or quality issues on a daily basis• Communicated effectively, both verbally and in writing, with customers, sales, marketing, and operations to ensure production quality, enhance laboratory productivity, and increase profitability• Oversaw and maintained all QA/QC Lab budgets• Responsible for hiring/firing, training, and administration of personnel issues• Designed, implemented/supervised and performed all analytical validations and daily testing required for quality control• Operated and calibrated HPLC, GC, UV spectrophotometer, autotitrators, centrifuge, viscometers, pH meters, and various other equipment required for analytical chemistry• Completed computer records, notebooks, reports, investigations, and other paperwork necessary to maintain the Analytical Lab and release material for filling or shipping• Led or assisted with customer and regulatory audits• Employed aseptic technique to perform micro testing for product release• Performed plate reading on finished tests to release material for filling or shipping Show less

• Provided supervision and research assistance for 4 to 15 graduate students• Independently performed sterile tissue culturing techniques, nitrate reductase assays, Ames method for ATPase assays, SDS electrophoresis gels, and plasma membrane isolation using sucrose gradients and PEG/Dextran phase separation systems• Routinely responsible for the coordination of experiments, maintenance of plants, use of radioisotopes and maintenance of their records, data entry, filing, ordering, and… Show more • Provided supervision and research assistance for 4 to 15 graduate students• Independently performed sterile tissue culturing techniques, nitrate reductase assays, Ames method for ATPase assays, SDS electrophoresis gels, and plasma membrane isolation using sucrose gradients and PEG/Dextran phase separation systems• Routinely responsible for the coordination of experiments, maintenance of plants, use of radioisotopes and maintenance of their records, data entry, filing, ordering, and variety of other lab duties• Independently organized and conducted herbicide - soil leaching experiments • Performed sample preparation and sample analysis using HPLC and GC• Performed sterile culturing techniques for plant metabolism studies• Supervised daily maintenance of lab, including experiment preparation• Certified by Cornell University for the use of radioisotopes, performed maintenance of radioisotope use and storage records Show less