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Associate Scientist II, Quality Control

Arrowhead Pharmaceuticals
Verona, USA
Junior · 1+ years experience
Onsite
USD 70000-85000 / year
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Requirements

  • Masters in Chemistry (or related field) with 1+ years’ relevant laboratory experience in pharmaceutical/regulated environment or Bachelors in Chemistry (or related field) with 3+ years in a GMP QC or analytical laboratory environment.
  • Experience with cGMP laboratory requirements and operations
  • Familiar with analytical instrumentation, test methodology/validations, data acquisition systems, and cGMP policies and practices.
  • Preferred
  • Previous Environmental Monitoring and/or cleanroom experience.
  • Previous Microbiology experience.
  • Language Skills: Ability to read, analyze and interpret SOPs, test methods, procedural guides and associated technical documents. Ability to write in a clear and concise manner. Ability to effectively present information and respond to questions from management, peers and colleagues.
  • Mathematical Skills: Must be able to perform complex math functions, compute ratios, rate, and percent. Must be able to draw and interpret graphs and charts.
  • Reasoning Skills: Must be able to solve practical problems. Must be able to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
  • Other Skills and Abilities: Must be able to work with people at various levels of the organization. Must have basic knowledge of computers and PC’s. Ability to use windows-based software including MS Office and chromatography data collection software.
  • Wisconsin pay range $70,000—$85,000 USD
  • Arrowhead provides competitive salaries and an excellent benefit package.
  • Candidates must have current, valid authorization to work in the country where this role is located.
  • California Applicant Privacy Policy

Preferred Qualifications

  • Preferred

Responsibilities

  • Developing understanding and knowledge of cGMP requirements.
  • With guidance from laboratory leadership, works to meet project timelines and deliverables
  • Performs routine Environmental Monitoring sample collection within a cGMP Manufacturing space.
  • Performs routine analytical testing of pharmaceutical raw materials, in-process samples, finished products and/or stability samples using established test methods and procedures
  • Executes training requirements, applies relevant SOPs and associated procedural guides
  • Ensures that training records are up to date and in compliance
  • Familiar with various analytical instrumentation theory and practice
  • Trains on, and becomes proficient with, a variety of analytical instrumentation (e.g., HPLC, GC, FT-IR, UV/Vis, KF, etc.)
  • Can set up various instrumentation for testing according to written test methods with little to no supervision
  • Plans and executes work related tasks with minimal supervision
  • Performs analyses in a timely manner
  • Works collaboratively with others
  • Shows initiative and interest in learning new techniques and tests
  • Identifies and troubleshoots minor analytical problems with instrumentation, general chemistry and computer applications
  • Quickly communicates analytical or sample issues to senior staff and/or management
  • Maintains a clear, concise and accurate laboratory notebook or worksheet records.
  • Reviews test data acquired by others, as applicable.
  • Aids with the drafting of technical documents such as OOS/atypical investigations, deviations and CAPAs
  • Possesses good written and verbal communication skills
  • Consistently and correctly analyze data/results and interpret outcome of experiments and to propose appropriate follow-up with supervision.
  • Embraces cGMP requirements for all associated work
  • Works cooperatively in a team environment
  • Developing attention to detail
  • Calibration, maintenance, and troubleshooting of analytical equipment with supervision.
  • Remains flexible with changing priorities
  • Additional duties as assigned

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