Instructor of Chemistry and Earth Science

Provided approximately 128 8th graders with science curriculum designated by Wake County Public School System.

Responsible for developing and validating analytical methods for testing of drug substances and drug products using HPLC, UPLC, Dissolution, KF and other laboratory equipment. Supply weekly updates on long-term projects. Prepare well written and organized development reports to convey the quality of the methods to clients. Assist in writing new SOPs, implementing efficient and effective workflows, and onboarding new methods and instruments. Draft and release certificates of analyses, reports, protocols and methods per cGMP and ICH practices

Perform assigned sampling, physical, chemical tests and assay on raw materials, active pharmaceutical ingredients, in-process, finished and stability products, using various wet chemicals, physical and instrumental techniques (HPLC, UV-Vis, Particle Size Analyzer, KF Auto titrator, and other routine QC instruments) as per as per USP monograph / In-house / any other Compendial monographs.Work with supervisor to plan and make adequate inventory of test reagents and solutions to perform work, assure supplies are ordered as needed to perform assigned work.Work with supervisor to plan and execute testing to meet established time lines. Perform complicated testing with supervisory direction.Record data and results as specified in documentation procedures. Document work clearly and perform tests accurately.Prepare and/or Review Test Procedures, SOPs, and Protocols as assigned.Perform maintenance and calibrations of laboratory instruments/equipment with supervisory direction/training as needed.Perform troubleshooting and investigations under the direction of a supervisor.Comply with all regulatory/in-house requirements (may include but not limited to safety, house keeping, laboratory chemical waste, cGMP, cGLP, documentation) when performing the assigned activity.Review of Analytical documents as required

Perform assigned sampling, physical, chemical tests and assay on raw materials, active pharmaceutical ingredients, in-process, finished and stability products, using various wet chemicals, physical and instrumental techniques (HPLC, UV-Vis, Particle Size Analyzer, NGI cascade impactor, KF Auto titrator, Bulk Density, and other routine QC instruments) as per as per USP monograph / In-house / any other Compendial monographs.Work with supervisor to plan and make adequate inventory of test reagents and solutions to perform work, assure supplies are ordered as needed to perform assigned work.Work with supervisor to plan and execute testing to meet established time lines. Perform complicated testing with supervisory direction.Record data and results as specified in documentation procedures. Document work clearly and perform tests accurately.Prepare and/or Review Test Procedures, SOPs, and Protocols as assigned.Perform maintenance and calibrations of laboratory instruments/equipment with supervisory direction/training as needed.Perform troubleshooting and investigations under the direction of a supervisor.Comply with all regulatory/in-house requirements (may include but not limited to safety, house keeping, laboratory chemical waste, cGMP, cGLP, documentation) when performing the assigned activity.Review of Analytical documents as required

Perform assigned sampling, physical, chemical tests and assay on raw materials, active pharmaceutical ingredients, in-process, finished and stability products, using various wet chemicals, physical and instrumental techniques (HPLC, UV-Vis, Particle Size Analyzer, NGI cascade impactor, KF Auto titrator, Bulk Density, and other routine QC instruments) as per as per USP monograph / In-house / any other Compendial monographs.Work with supervisor to plan and make adequate inventory of test reagents and solutions to perform work, assure supplies are ordered as needed to perform assigned work.Work with supervisor to plan and execute testing to meet established time lines. Perform complicated testing with supervisory direction.Record data and results as specified in documentation procedures. Document work clearly and perform tests accurately.Prepare and/or Review Test Procedures, SOPs, and Protocols as assigned.Perform maintenance and calibrations of laboratory instruments/equipment with supervisory direction/training as needed.Perform troubleshooting and investigations under the direction of a supervisor.Comply with all regulatory/in-house requirements (may include but not limited to safety, house keeping, laboratory chemical waste, cGMP, cGLP, documentation) when performing the assigned activity.Review of Analytical documents as required

Perform high complexity immunological testing, including ELISA and total immunoglobulin assays.Demonstrate basic knowledge of immunological assays.Transcribe data that has been produced automatically by an instrument or computer generated.Assist with pre-analytical preparation: (e.g. uncap/cap specimen tubes, prepare racks, worklists, enter/scan specimens and load automated instruments.)Record digital temperature; notify licensed personnel if temperature is out of range.Assist with instrument preventive maintenance and troubleshooting; recognize instrument software/operating error messages; recognizes equipment malfunctions and failures and notifies the supervisor.Assist with monitoring the department pending and overdue lists which includes, searching, locating, following up and filing appropriate documentation (e.g. Test Not Performed (TNP), Missing Specimen (MSP), Quantity Not Sufficient (QNS), tracking notes.)Monitor quality control criteria and instrument maintenance/performance and file corrective action forms when discrepancies occur.Perform other departmental tasks such as filing, generating reports, requisitions/other paperwork.Attend departmental meetings as required.Follow established procedures for obtaining and processing biological specimens for analysis in the department.Ensures the automated analytical results are accurately recorded on the designated worksheets and communicates the results to supervisory personnel for checking and verification.Performs routine quality control procedures and records the results accurately on appropriate log sheets. Recognizes out of range control results and notifies supervisory personnel.Participates in annual proficiency and competency evaluation requirements.Follows appropriate safety practices in the laboratory at all times.Follows company guidelines and regulations.Any other duties for which the General Supervisor has made the Laboratory Technologist a Designee.

Follow established procedures for obtaining and processing biological specimens for analysis in the department.Assist with the preparation of reagents and solutions using approved procedures.Perform labeling, handling, process/preparation and storage of specimens.Clean, organize and maintain work area and laboratory equipment, as needed.Communicate information/problems to appropriate individuals.Maintain awareness and keep abreast of new developments and/or changes in policies and procedures.Read written and electronic communications, postings and protocols. Attend departmental meetings as required.Follows company guidelines and regulations.Follows appropriate safety practices in the laboratory at all times.Assists in monitoring and recording data from digital temperature and humidity meters and notifyingthe appropriate individuals when out of range.Performs other duties as assigned.

Proficient in multiple laboratory techniques and demonstrates an in depth understanding of one or more core laboratory techniques.Follows and is able to modify and author all applicable SOP’s, ICP’s, IQS’s, ATM’s and TTP’sDocuments all laboratory work to meet Catalent Pharma standards.Author testing protocols.Trains analysts in moderate to complex techniques.Under general supervision, communicates with sponsors and the public.Able to work effectively on any lab team.Capable of recognizing data trends with supervisory guidance.Contributes to a generation of substantial technical reports (results and discussion).Ability to organize time for multiple tasks.Able to bring projects to a timely completion using Catalent Pharma systems.Coordinates and performs assigned projects.Keeps up with pharmaceutical publications.Responsible for the collection and transfer of waste outlined in annual training and hazardous waste guidelines.