Associate Scientist, Quality Control

The Position

This position is within the Quality Control structure under the Quality Department. An Associate Scientist I, Quality Control will support the analytical testing of 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 I will also support testing required for GLP Toxicology and cGMP Clinical Trial material release, as well as stability studies. The Associate Scientist I is expected to perform several analytical techniques and can make sound scientific decisions under guidance from management. This position reports to QC Laboratory Management.

Responsibilities

• Developing knowledge of cGMP requirements
• With guidance from laboratory leadership, works to meet project timelines and deliverables
• 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

Requirements:

• B.S. in Chemistry (or related field) with 1-3 years of relevant laboratory experience
• Experience with cGMP laboratory requirements and operations
• Familiar with analytical instrumentation, test methodology/validations, data acquisition systems, and cGMP policies and practices