Maxine R.

Experience

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  Teva Pharmaceuticals

  Jan 1989 - Jan 2000

  Senior Chemist

  Performed complex chemical/physical analysis on samples according to established procedures (USP, BP, EP and House Methods).Developed and created laboratory-testing templates to meet all regulatory requirements.Competent in the use of complex trouble-shooting techniques.Supervised, instructed, and provided training to new and less experienced chemists in various analytical techniques, instrumentation, SOP’s, as well as, health and safety procedures.As a senior chemist, coordinated work for analysts, ensured the work was completed on time, documentation properly organized and submitted to the auditing group.Performed tests specific to raw material, such residue on ignition, heavy metals, arsenic, specific rotation, loss on drying, Karl Fisher-moister determination, seleniumPerforming analytical testing of Finished Products and Raw Materials using variety of instrumentations such as, HPLC, UV-VIS, FTIR, Karl Fisher, GC, Particle Size Analysis.Performed assay, content uniformity, dissolution, impurity tests, residual substance using HPLC and process the results in EmpowerPerformed disintegration, friability and hardness tests by USP, BP, EP and House MethodsResolved analytical problems and carried out investigations using troubleshooting skills and related experience.Performed supervisory functions in the absence of laboratory supervisor. Show less

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  Teva Pharmaceuticals

  Nov 2000 - Jan 2018

  Performed comprehensive investigations for quality deviations (DR’s) related to analytical failures (OOS), packaging processes and validation.Performed comprehensive and detailed investigations for customer product and packaging complaints.Coordinated with relevant department’s failure notifications and procurement of various documents for review.Prepared internal preliminary investigations in respond to quality alerts and critical complaints and responded to senior management in a timely manner.Preparation of Quarterly Complaint trend reports.Participated in internal facility audits.Communicate and interact directly with various departments to resolve quality issues.Performed quality assessments related to controlled environment excursions (temperature and humidity monitored by a BAS system)Performed product impact assessments related to outbound temperature excursions.Performed review of implemented CAPAs and determined their effectiveness. Reviewed and approved laboratory investigations, deviations and calibration OOS investigations.Reviewed and approved various documentation generated by the QC lab and AR&D laboratory including SOPs, change controls for specifications, new and revised analytical methods, training & qualification procedures, method transfer protocols/reports, method validation protocols/reports and analytical instrumentation qualification Performed annual product review on domestic and US products.Received and process retained samples (raw materials, finished products, bulk samples) for storage and updated applicable QMS. Destruction of Retained samples (raw materials, finished products, bulk samples)For product failure notification, placed rejected or hold stickers on affected product lot (s) and updated ERP system. Good working knowledge of MasterControl, Sage, LIMS, TrackWise and Oracle.Knowledge and ability to execute statistical sampling, AQL/ANSI interpretation.Prepare monthly reports related to Quality Assurance. Show less Coordinated, delivered and evaluated in-class technical training on GMP, SOP’s, and Training and qualification for the Quality Control Department (approximately 150 personnel) on an individual basis and team environment.Attended team building sessions.Designed and developed training programs.Organized, revised and continually updated all QC lab training manuals and procedures, records, and management reports of employee training/retraining consistent with regulatory requirements.Coordinated, integrated and maintained the QC lab training record management database system.Provided coaching to new staff on laboratory procedures (GMP’s, SOP’s, Training and qualification, and health and safety). Show less

  • Quality Assurance Associate

    Jan 2006 - Jan 2018

  • Technical Training Specialist (Quality Control Laboratory)

    Nov 2000 - Jun 2006
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  Aurora Cannabis Inc.

  May 2020 - Mar 2022

  Quality Assurance Associate

  • Lead, participated and prepared risk assessments and preventive control plans from a Quality Assurance perspective.• Performed investigation of customer complaint received in respect of the quality of the cannabis to ensure regulatory compliance and customer satisfaction. • Collaborated with internal stakeholders including but not limited to: Operations, Quality Assurance, Quality Control, Regulatory teams at both site and global Aurora level for the investigation and closure of non-conformances.• Reviewed third party lab testing results to ensure compliance to specifications.• Reviewed harvesting, trimming and defoliation batch documentation based on internal SOPs, Health Canada requirements and quality standards and prepared the documents for market released. Show less