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