Experience

BioAgilytix

• United States
• Biotechnology Research
• 700 & Above Employee

• QA Auditor II at Bioagilytix

  • Feb 2022 - Present

   Performs Quality Assurance (QA) audits for GCP/GCLP/GLP regulations, inspections, databases and monitoring procedures against SOPs, methods, protocols/plans, guidance’s, and/or regulations.  Issues QA statements for reports as needed, assists in document management activities and assists in writing and reviewing QA SOPs.  Assists in hosting regulatory inspections by acting as scribe and/or reviewing documents and identifying and calling operational stuff to answer questions as required.  Obtains and maintains professional and technical knowledge by attending educational workshops; reviews professional publications; establishes personal networks.  Perform duties with minimal QA Management oversight. Show less



Thermo Fisher Scientific

• United States
• Biotechnology Research
• 700 & Above Employee

• Validation Engineer II

  • Sep 2020 - Feb 2022

   Provide direct quality support to the business unit, clients and corporate management. Create, review, approves, track and present documents required for compliance with pharmaceutical regulations such as validation documents, clinical trial material assessments, validation project plans, etc. Prepare, review and approve validation, hold, investigation and audit reports; gains multidisciplinary consensus; makes recommendations to management based on review and analysis of data. Manage, schedule, execute and track multiple project activities of moderate complexity with multidisciplinary departments to ensure timely completion of deliverables. Assess impact of changes in systems, critical documentation, processes and suppliers. Identify critical parameters/processes and take appropriate actions to ensure adequate controls are in place. Conduct deviation investigations, such as validation failures, complaints and hold investigations. Identify appropriate corrective actions and perform and assist with risk assessments for processes and systems. Show less

• QC Scientist II

  • Sep 2019 - Sep 2020

   Prepared documentation for release testing, investigations, and validations of protocols and reports. Work in a fast-paced, client timeline dedicated position to deliver results quickly and right first time. Participate in GEMBA walks to ensure the highest quality of work is provided. Participate in the Data Integrity team to aid the site in minimizing the number of audits and maximizing the efficiency of the team. Use Empower 3.0 to support testing of routine and non-routine analyses, analyze data to determine trends, acceptability, identify deviations and assure resolution of deviations. Use SLIM, LIMS, Documentum, Trackwise to maintain well-documented logbooks and records. Exceptional attention to detail and organizational skills, able to multi-task, effective time management and prioritization skills. Comply with all job-related safety and other training requirements. Show less



Recipharm

• Sweden
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Specialist

  • Mar 2019 - Sep 2019

   Provided direct quality support to ensure compliance with regulations by ensuring the quality of laboratory data and reports.  Provided technical leadership and quality oversight for inhalation testing and ensured highest levels of compliance to deliver customer satisfaction.  Used Empower 3.0 and Class VP to review and interpret data.  Performed document review to determine if the work performed adheres to current regulations, SOPs, cGMP, etc.  Supported investigations, report writing, CAPAs, LIs, OOS/OOT results and worked closely with team leads and managers to come to a consensus.  Daily interactions with personnel to aid with documentation corrections in order to facilitate an efficient workflow.  Communicated with the Customer to ensure the highest level of quality and regulatory requirements are being met.  Managed shipping/receiving of samples, standards, reagents, etc to ensure the regulatory requirements are being upheld.  Performed document reviews and made determinations as to whether work performed meets current procedures and regulatory expectations. Show less



Tergus Pharma

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Specialist

  • Apr 2018 - Feb 2019

   Ensure the quality of laboratory data and reports by efficiently and effectively reviewing chromatographic/other data and related notebooks as specified by Standard Operating Procedures (SOPs).  Evaluate data to ensure compliance with analytical methods, client criteria, and Good Manufacturing Practices (GMP).  Understand and interpret analytical data for routine and non-routine testing to ensure compliance, accuracy, and completeness of work as well as results based on documented data.  Use Empower 2.0 to review and interpret data.  Write, review and verify reports, SOPs, Specifications, Analytical procedures, etc.  Prepare written reports with recommendations for corrective and preventative actions to problems and changes to procedures to ensure high quality is the company standard.  Interpret a variety of instructions furnished in written, oral, diagram, or schedule form.  Ensure compliance with company policies and SOPs as well as FDA and other applicable guidelines.  Perform audits, including focused and general audits of Operations and Quality Assurance areas against cGMP standards and ensures resolution of any identified issues.  Use SLIM (Stability Laboratory Information Management) to accurately track stability samples. Show less



Mayne Pharma

• Australia
• Pharmaceutical Manufacturing
• 400 - 500 Employee

• R&D Chemist

  • Sep 2016 - Mar 2018

   Followed all regulatory guidelines, cGMP guidelines and Environmental Health and Safety regulations as required.  Performed routine and non-routine testing for chromatographic and spectrophotometric methods of analysis in support of pharmaceutical API and product development.  Testing of assays (potencies, related substances, residual solvents, metals, etc.) and rate of release (dissolution).  Performed composite assay, related compound, dissolution and all other related testing on finished products (including stability) in accordance with FDA stability guidelines.  Developed methods and validated analytical techniques on a variety of instrumentation, including but not limited to: HPLC, UV, Dissolution, GC, etc.  Prepared documentation for release testing, investigations, and validations of protocols and reports.  Used Empower 2.0 to support testing of routine and non-routine analyses, solved problems with a single method, instrument or process, interpreted data, draws conclusions, and makes recommendations to team.  Worked in a GMP environment using PPE on an assortment of instrumentation.  Followed established procedures and document all findings and results in a laboratory notebook in a timely, concise, clear, and accurate manner. Show less