Associate Scientist 2 - Quality Control

The Position

This position is within the Quality Control structure, under the Quality Organization.  An Associate Scientist II, Quality Control will support the analytical testing of Environmental monitoring samples, pharmaceutical raw materials, in-process samples, finished drug substances and drug product, and/or stability sample testing activities for new drug substances and drug products.  The Associate Scientist II will also support testing required for GLP Toxicology and cGMP Clinical Trial material release, as well as stability studies.  The Associate Scientist II is expected to perform several analytical techniques and can make sound scientific decisions with guidance from management.  This position reports to QC Laboratory Management.

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

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 70000 - 85000 USD