Document Control and Training Specialist, administrator of the electronic Quality Management System (eQMS). • Maintain, update, review, approve, and implement documentation within the eQMS (eTQ Reliance)• Perform data analysis and quality metrics, hosting the weekly Quality Assurance Metrics Meeting• Conduct internal audits• Develop and conduct training relating to quality management• Advise and coordinate production staff training• Administrative responsibilities for… Show more Document Control and Training Specialist, administrator of the electronic Quality Management System (eQMS). • Maintain, update, review, approve, and implement documentation within the eQMS (eTQ Reliance)• Perform data analysis and quality metrics, hosting the weekly Quality Assurance Metrics Meeting• Conduct internal audits• Develop and conduct training relating to quality management• Advise and coordinate production staff training• Administrative responsibilities for eQMS modules including CAPA, NCR, Supplier Quality (approver suppliers)• Project management responsibilities for all standards ensuring they are up to date and gap assessments are completed as required. Show less

Laboratory analysis, batch data management, and protocol development in a GMP facility to support drug production for phase I-IV clinical trials and commercial use.• Performed compendial quality testing including Appearance, Color, Clarity, pH, Conductivity, Osmolality, Density, Viscosity, Moisture content, Syringe/Auto-injector Functionality, Extractable Volume, and Container Closure Integrity Testing per USP (United States Pharmacopeia) and EP (European Pharmacopoeia) regulations for… Show more Laboratory analysis, batch data management, and protocol development in a GMP facility to support drug production for phase I-IV clinical trials and commercial use.• Performed compendial quality testing including Appearance, Color, Clarity, pH, Conductivity, Osmolality, Density, Viscosity, Moisture content, Syringe/Auto-injector Functionality, Extractable Volume, and Container Closure Integrity Testing per USP (United States Pharmacopeia) and EP (European Pharmacopoeia) regulations for in coming drug material, in-process drug substance, and final release of drug product• Performed complex quality testing including enzyme activity, identification, purity, and concentration via cuvette or plate based SpectraMax spectrophotometer methods, SoloVPE methods, ELISA (enzyme-linked immunosorbent assay), AGE (agarose gel electrophoresis), SDS-PAGE, Western Blot, Dot Blot, CE-SDS for in coming drug material, in-process drug substance, and final release of drug product• Reviewed and authored SOPs (Standard Operation Procedures), controlled forms, qualification protocols, and qualification reports • Generated Certificate of Analysis (CoA) and Certificate of Testing (CoT) for batch disposition• Represented Quality Control during batch disposition meetings ensuring data packets are available to meet lot release deadlines• Participated in Client and Safety Audits • Experienced in Out of Specification Investigations, Deviation and CAPA (Corrective and preventive action) reports• Developed new training program for Quality Control analysts and acted as the primary trainer of new analysts within the QC Chemistry group• Ensured lab equipment preventive maintenance and calibration were complete on schedule• Good working knowledge of Master Control document control system, LIMS sample manager, and QAD ERP system•Played a large role in organizing and implementing 6S Sigma throughout QC laboratories Show less

Used sophisticated laboratory equipment in an ISO 9001:2015 certified cleanroom to manufacture biological media and chemicals for life science research• Performed aseptic and analytical procedures to create high quality products• Manufactured products in accordance with international standards (ISO and cGMP)• Followed standard operating procedures (SOP) and other guidelines to meet product specifications and required quantitative quality measures while meeting… Show more Used sophisticated laboratory equipment in an ISO 9001:2015 certified cleanroom to manufacture biological media and chemicals for life science research• Performed aseptic and analytical procedures to create high quality products• Manufactured products in accordance with international standards (ISO and cGMP)• Followed standard operating procedures (SOP) and other guidelines to meet product specifications and required quantitative quality measures while meeting deadlines• Routinely evaluated, calibrated, and maintained laboratory equipment• Participated in continuous improvement project problem solving groups• Kept extensive and detailed records of all processes performed• Sourced and ordered equipment and supplies as part of the department purchasing team Show less

Organized and supervised laboratory production team to extract oils from raw organic material, developed and produced oil based products, and package for sale in accordance with Health Canada regulations• Scheduled exaction team and calibrated with sales to ensure order fulfillment • Prepared products for sale from raw material, including processing, formulation, and packaging• Prepared stock solutions, anticipating their use during lab tasks• Composed… Show more Organized and supervised laboratory production team to extract oils from raw organic material, developed and produced oil based products, and package for sale in accordance with Health Canada regulations• Scheduled exaction team and calibrated with sales to ensure order fulfillment • Prepared products for sale from raw material, including processing, formulation, and packaging• Prepared stock solutions, anticipating their use during lab tasks• Composed, troubleshot, and redesigned standard operating procedures for sample preparation• Maintained lab inventory, including ordering chemicals and material• Organized and implemented Health and Safety duties for several departments, including equipment inspection and management of safety data sheets Show less

Chemical extractions and analysis to support research into hydrocarbon degradation in seawater.• Extraction lab work includes preparing samples for gas chromatography, mass spectrometry, and flame ionization detector (FID) analysis• Often prepared stock solutions and internal standards according to precise methods• Responsible for tensiometry and fluorometry data collection• Responsible for problem shooting, redesigning, and making methods for sample preparation… Show more Chemical extractions and analysis to support research into hydrocarbon degradation in seawater.• Extraction lab work includes preparing samples for gas chromatography, mass spectrometry, and flame ionization detector (FID) analysis• Often prepared stock solutions and internal standards according to precise methods• Responsible for tensiometry and fluorometry data collection• Responsible for problem shooting, redesigning, and making methods for sample preparation in collaboration with co-workers Show less

Supervised, scheduled, and trained front end staff (70+ employees). Recorded and accounted for all in-store transactions. • Participated in the management training program. • Duties in cash office included recording and accounting for all in-store transactions as well as ensuring any related issues were resolved. • Scheduled 70+ front end employees• Supervisory duties involved coordinating cashiers and addressing customer grievances• Trained many… Show more Supervised, scheduled, and trained front end staff (70+ employees). Recorded and accounted for all in-store transactions. • Participated in the management training program. • Duties in cash office included recording and accounting for all in-store transactions as well as ensuring any related issues were resolved. • Scheduled 70+ front end employees• Supervisory duties involved coordinating cashiers and addressing customer grievances• Trained many employees to operate cash registers, work the customer service desk, and perform duties in the cash office• Interacted with community members through Sobey’s community events Show less

Supervised, assisted and graded students completing chemistry course laboratory components• Instructed in the lab for general chemistry, organic chemistry, and biochemistry• Guided students through use of nuclear magnetic resonance spectrometer, ultraviolet spectrometer, infrared spectrometer, and rotary evaporators as well as basic laboratory techniques (use of various pipettes, burettes, scales, columns, etc)• Prepared laboratory space prior to and following student… Show more Supervised, assisted and graded students completing chemistry course laboratory components• Instructed in the lab for general chemistry, organic chemistry, and biochemistry• Guided students through use of nuclear magnetic resonance spectrometer, ultraviolet spectrometer, infrared spectrometer, and rotary evaporators as well as basic laboratory techniques (use of various pipettes, burettes, scales, columns, etc)• Prepared laboratory space prior to and following student use of equipment• Developed and followed contingencies when students fell behind or equipment failed• Ensured laboratory safety procedures were followed at all times•Marked labs and quizzes according to department guidelines • Independently arranged to meet students privately to provide extra instruction and address concerns Show less