Sarah J Powers

• Guest lecturer
• Panel discussions
• Strategic planning of the educational program
• Advised students on educational, career and social opportunities.
• Delivered supportive and knowledgeable counseling to students with academic concerns.

Manage Stability Program as follows:

• Author stability sections of Regulatory Submissions (IND, NDA, BLA, etc.), and respond to regulatory questions
• Responsible for providing effective leadership to manage stability program
• Ensure compliance with national (FDA) and international (EMA) regulations and pharmacopeia, making continuous improvements accordingly
• Support current shelf-life of products, with extensions of shelf-life based on stability data and trends
• Manage real-time trending and analysis of stability data
• Manage Out-of-Trend/Out-of-Specification investigations for lots on stability
• Maintain stability -related quality systems including temperature excursions, deviations, change controls, CAPAs, etc.
• Author stability sections of annual product reviews, with support of stability data and tables
• Manage coordination of stability samples sent to external testing laboratories
• Author/revise stability policy documents, risk assessments and SOPs as needed
• Manage department training requirements and training for SMS system (Veeva)
• Drive and manage specification through collaboration and gmp documentation
• QC Representative with CMC team: align on critical item, maintain communication both up and down projects

Manage Stability program as follows:

• Manage and coordinate all stability studies within the QC department
• Coordinate storage and retrieval of stability samples with outside vendor
• Write protocols and reports for stability studies that comply with USP and ICH guidelines
• Perform data trending and statistical analysis for ongoing stability studies utilizing JMP software
• Keep current with stability regulations and update procedures as necessary
• Coordinate internal & external outsourcing and testing with vendors
• Manage retain program for released product batches and coordinate storage with outside vendor
• Analyze testing results and write analysis reports
• Perform trending on data review observations and conduct training to reduce the laboratory documentation errors and to increase efficiency, update QC management on any observed trends
• Support QC and QA management during regulatory, customer, corporate, and internal audits/inspections
• Support the generation of APRs with regards to QC data
• Proactively look for trends in industry regarding GMP’s and good documentation practices in the QC laboratory
• Work with analysts for document corrections and provide guidance accordingly
• Guide analysts on laboratory notebook documentation requirements
• Participate in quality, cGMP, safety, method, and technique training appropriate for the respective area. Part of the “Front Room” team for inspections.
• Lead audit for external suppliers to OTX:
• Travel to external suppliers
• Create agenda and coordination with supplier
• Audit supplier for GxP requirements based on needs
• Writes and creates report for supplier based on audit results, with follow up as needed
• Supervise direct reports within department

• Performs Analytical Data Review duties
• GMP trained – both FDA and EU
• Review and approval of all Quality Data: wet chemistry, analytical, outside testing
• Review and approve validation data for Analytical Development
• Coordinate timely review of laboratory notebooks, analytical data, and reports from both QC and AD area
• Ensures all testing/analysis is conducted according to approved test methods, standard operating procedures or associated documents and meets the product specific requirements. Checks all associated calculations, raw data and verifies all reagents, standards and equipment used are within the acceptable range.
• Review audit trails and instrument logs on gGMP instrumentation and equipment for laboratory data release
• Notifies chemist and department management of any observed lab events including Non-Conformance, Out of Trend, and Out of Specifications.
• Perform detailed data review for analytical test results generated by contract testing labs to assure their correctness and accuracy.
• Reviews technical documents, certificate of analysis, analytical test record, stability data sheet, reference standard qualification reports, and materials
• Reviews validation data and reports
• Reviews test method transfers data and reports
• Write and review SOPs, Validations, and Stability Reports
• Approved SOP, and Test Method Transfer
• Manage and maintain all sample submissions to the QC group to document control filing
• Coordinate with other vendors for outside testing, quotes, shipping, and report reviewing
• Support the generation of APR with regards to QC data
• Ownership of control charting of QC data
• Proactively look for trends in industry regarding GMP’s and good documentation practices in the QC laboratory
• QC subject matter expert for external audits
• Support QC/QA management during regulatory, customer, corporate, and internal audits
• Interview incoming candidates for multiple departments

• GMP trained
• Analytical Services Coordinator: Lead direct reports, Testing, Review, and approval of all Raw Materials and Research samples
• HPLC, UPLC, CAD, GC-FID, KF, FTIR, Refractometer, UV-VIS, Moisture Analyzer, Wet Chemistry
• Run Empower2 & Empower3 software to analyze data
• Review and approval of data
• Environmental Monitoring & Quarterly Report Generation
• Routine maintenance on each system/troubleshooting as necessary
• Write and review SOPs, Validations, Stability Reports
• Transfer method conversion

• EPA Methods 524, 624, 8260, 625, 8270, 8081/8082, EPH, TPH, VPH
• Analyze client samples using Tekmar Auto samplers, Gas chromatographs, Mass spectrometers, ECD, FID, PID, HPLC
• Run Chemstation Software to analyze data
• Routine maintenance on each system, and maintain all laboratory equipment
• Peer review data for clients using LIMS

• Analyze client water and soil samples for Escherichia coli, Enterobacter aerogenes, and Pseudomonas aeruginosa using Heterotrophic Plates, Membrane Filtration, Tube Cultures, and MPN Trays

• Total Nitrogen, ammonia, carbonaceous oxygen demand, biological oxygen demand, phenol, and hexavalent chromium detection methods

• Login and keep custody of client samples
• Analyze the water samples using a Centurion Auto sampler or Tekmar 2016, 5890 Gas Chromatographs, 5971/5972 Mass spectrometers
• Run Chemstation Software to analyze data
• Do routine maintenance on each system, and the lab

• Login and keep custody of client samples
• Analyze the water samples using an Arkon auto sampler, Gas chromatograph, and Mass spectrometer
• Run Chemstation Software to analyze data
• Do routine maintenance on each system, and the lab
• Peer review data for clients