Completely, accurately and precisely prepares all laboratory reports and/or test scripts and documents in accordance with cGDP and cGMP requirements
Demonstrates high ethical standards
Maintain current training status on relevant equipment and procedures Comply with all cGMP, regulatory, corporate and EHS requirements
Demonstrates ability to multi-task and prioritize work
Maintain laboratory in audit readiness per cGDP and cGMP practices
Perform peer review for testing and calculations, as necessary
Recognizes Out of Specification, atypical and/or anomalous data, escalates to management, as necessary
Perform analytical testing and calculations on in-process bulk material, finished product, cleaning and customer samples span
Receive and prepare reagents and standards
Air dryer testing
Perform Calibration Checks (Balance/pH/Conductivity/Pipettes etc.)
Perform Rinse Water testing: TOC, Conductivity Perform Raw Material Water testing: Nitrates Operate analytical instrumentation HPLC, UV/Vis, Balances, Densitometer, Autotitrator, pH meter, Conductivity Meter, Total Organic Carbon Analyzer (TOC), Osmometer, Viscometer, Karl Fischer, Particle Counter, Malvern, Polarimeter, Microscope.. (trained on NLT 11 laboratory instruments)
Perform pH adjustments
Perform Viscosity Ostwald viscosity
Perform Batch release testing
Perform First Acceptable testing Cromolyn Sodium, Tobramycin cleaning, Budesonide, Levofloxacin, GNE and Identifications HPLC: NLT 3 HPLC assays i.e. Arformoterol Tartrate, Levalbuterol, other.
Autotitrator: All products and titrant standardizations
Wet Chemistry testing of in-process bulk material, finished product, TLC, Deliverable Volume, Opalescence, Degree of Coloration Prepare and generate reports to support Critical System Release
Other duties as assigned
Maintain analytical trending and metric tracking
Trains other analysts in routine testing, as necessary
Supports laboratory investigations and/or studies, as necessary'
Proficient in one of the three: Deviation or OOS/OOTr or Change Control
Must be able to initiate and complete LIR
Global TrackWise workflow for Deviations or Laboratory Investigations or Change Control
Education or Equivalent:Bachelor of Science in Chemistry or Sciences or equivalent work experience
Experience: Experience in a lab setting (academic, intern or other)
Demonstrated intermediate mathematical ability.
High level of attention to detail, well organized and multi-task oriented.
Excellent documentation skills.
Strong communication skills both written and oral.
Strong problem solving and analytical skills.
Works well in a team environment with a variety of individuals and personalities within and between departments.
Review reports, etc. for accuracy and logic.
Must be able to multitask, be proactive and willing to take initiative and responsibility.
Should be familiar with cGMP and safe work practices.
Maintain good records and be able to access them rapidly.
Understand where information can be found.