Experience

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  Catalent pharma solutions

  Jun 2014 - now

  To assist and supervise the Stability team members (technicians) as necessary as they process incoming samples, conduct set-downs, pulls, destruction and any sampling handling activities. In general, support activities within the Stability group of the Site Operations Support Department. Function as a Stability technical lead interact with external and internal customers as needed for project support or regulatory support and mentor or provide technical guidance to Stability associates. Coordinate, schedule, delegate, perform and/or support the job functions of the Stability including sample receipt, sample distribution, sample disposition and accompanying electronic (Track-IT, GLIMS, SIS) or paperwork documentation. Review existing practices, author, co-author and/or revise procedures/methods/SXP’s as appropriate. Prepare and/or review shipping paperwork as needed. Prepare mid-year and year-end associate reviews, complete HR activities (time entry approval, PTO approval, salary adjustments, etc.), supporting client audits/visits, and communicating with cross-functional teams on analytical activities. Serve as backup to the SOS II Manager functions as needed. Show less Physically receive, count, label, and organize samples/standards for the purpose of further distribution. Activities include handling temperature recording devices (stopping, starting, and interpreting or providing data to clients). Perform registration activities for all samples and standards into the chain of custody software. Communicate effectively with internal customers (project management, operations, and laboratory personnel) to facilitate efficient sample flow. Input and submit storage and distribution charges monthly.Obtain DEA clearance and participate in controlled substance inventory verification. Responsible for responding to chamber alarms and assisting with sample impact/resolution. Perform support activities for/on behalf of the Quality Control department. Develop and execute work plan or schedule for self and junior members of the team.Maintain high quality documentation in accordance with applicable regulatory guidance and site SOPs documenting work as appropriate within notebooks, forms, etc. Execute procedures or methods of increasing complexity with high quality and reviews own work to ensure accuracy and completeness. Perform review of peer's documentation (of moderate complexity) for accuracy, thoroughness, and compliance. Able to identify larger quality/compliance gaps within the team. May participate in or draft deviations.Author technical documents, such as methods, forms, SXPs, training materials, and/or certificates of analysis with little to no guidance.Train, coach, or mentor others on technical material, applied business matters, &/or applicable compliance topics.Execute efficiency/compliance improvement projects with little to no guidance. Identify improvement projects/ideas within team processes.All other duties as assigned Show less Physically receive and count, sort, label, and organize samples by lot/condition/sample orientation for the purposes of stability study setups and/or pulls.Coordinate stability study set downs with the Stability Coordinators including all set down preparations and placing samples in the appropriate chambers.Perform sample set downs, staging, pulling and sample movements. Perform second person verification of all staged/pulled samples. Coordinate stability shipments and sample destruct.Communicate effectively with internal customers (Coordinators and Analysts) to facilitate the smooth conduct of project activities. Obtain DEA clearance and participate in controlled substance inventory verification. Perform support activities for/on behalf of the Quality Control department. Execute and provide input on assigned work plan or schedule as developed by the supervisor or senior team member.Maintain high quality documentation in accordance with applicable regulatory guidance and site SOPs documenting work as appropriate within notebooks, forms, etc. Execute procedures or methods of increasing complexity with high quality and review own work to ensure accuracy and completeness. May perform review of peer's documentation for accuracy, thoroughness, and compliance. Able to identify and remediate minor quality/compliance gaps during routine work.May edit technical documents, such as methods, forms, and/or certificates of analysis with direct guidance.May provide shadowing opportunities for training/orientation. Assist in the execution of efficiency/compliance improvement projects with guidance. All other duties as assigned Show less Under close supervision and guidance, performs tasks from detailed instructions and established procedures. Comply with site SXPs, corporate policies, and Environmental Health and Safety requirements. Applies technical skills and strong work habits to complete assigned work within own group/project team. A self-motivated, detail-oriented person who is able to make decisions and solve problems is essential. Able to work independently with little to no supervision, and flexible to also assist team members as needed.Physically receive and count, sort, label, and organize samples by lot/condition/sample orientation for the purposes of stability study setups and/or pulls.Assist with sample set downs, staging, pulling and sample movements. Perform second person verification of all staged/pulled samples.Communicate effectively with internal customers (Coordinators and Analysts) to facilitate the smooth conduct of project activities. May obtain DEA clearance and participate in controlled substance inventory verification. Perform support activities for/on behalf of the Quality Control department. Execute assigned work plan or schedule as developed by the supervisor or senior team member.Maintain high quality documentation in accordance with applicable regulatory guidance and site SOPs documenting work as appropriate within notebooks, forms, etc. Execute procedures or methods with high quality and review own work to ensure accuracy and completeness. Able to identify minor quality/compliance gaps during routine work. Participate in assigned improvement projects. All other duties as assigned Show less

  • Group Leader Stability

    Sept 2019 - now

  • Senior Laboratory Technician

    Sept 2017 - Sept 2019

  • Laboratory Technician II

    Apr 2016 - Sept 2017

  • Laboratory Technician 1

    Jun 2014 - Apr 2016