QC Associate II

The Associate II provides hands-on laboratory support for analytical method development, qualification, and routine testing activities. This role builds on foundational laboratory skills gained as an Associate I, taking on increasing independence for defined tasks and beginning to contribute to data analysis and documentation with reduced oversight.

Responsibilities

• Perform routine and development-phase analytical testing (e.g., HPLC, CE, GC, or compendial assays) under general guidance.
• Prepare samples, reagents, standards, and solutions accurately and in accordance with SOPs.
• Operate, maintain, and perform basic troubleshooting of laboratory instrumentation; escalate issues as needed.
• Record data accurately and maintain laboratory notebooks/records in compliance with GMP and good documentation practices.
• Contribute to method development experiments and qualification activities as directed by Scientist or Sr. Scientist staff.
• Support OOS investigations by providing data, sample history, or technical input as requested.
• Participate in team meetings, training sessions, and continuous improvement discussions.
• Perform routine GMP and stability testing after documented training/qualification, with general guidance and strict adherence to approved methods, specifications, and sample/timepoint requirements.
• Platform proficiency: Working proficiency in routine execution of one or more assigned platforms after documented training; performs defined testing with general guidance and increasing independence.
• Stability testing: Supports routine stability testing by ensuring correct sample/timepoint handling, timely execution, traceable documentation, and escalation of sample, scheduling, or result concerns.
• Method lifecycle and investigations: Supports development/qualification experiments and investigation activities through accurate execution, data capture, sample history retrieval, and documentation under scientist guidance.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, or a related scientific field (or equivalent hands-on laboratory experience).
• 3-5 years of relevant laboratory experience (including internships/co-ops).
• Familiarity with one or more analytical platforms (HPLC, CE, GC, or compendial/physicochemical testing).
• Working knowledge of GMP documentation practices.