Quality Control Associate

Job Summary

Seeking a detail-oriented Associate II, Analytical Development/Quality Control professional to support analytical testing, method development, and quality control activities within a regulated pharmaceutical or biotech environment. This role is responsible for executing analytical assays, maintaining data integrity, supporting investigations, and collaborating cross-functionally to ensure product quality and compliance with cGMP standards.

Responsibilities

• Perform routine and non-routine analytical testing of raw materials, in-process samples, and finished products.
• Support Environmental Monitoring activities and laboratory operations.
• Execute analytical assays using techniques such as HPLC/UPLC, GC, UV-Vis, and microscopy.
• Record, review, and maintain accurate laboratory data and documentation in compliance with GMP and GDP requirements.
• Assist with investigations related to out-of-specification (OOS) results and deviations.
• Support analytical method development, optimization, qualification, and transfer activities.
• Prepare technical documents including protocols, reports, and data summaries.
• Perform data review, trending, and quality assessments.
• Collaborate with Manufacturing, Quality Assurance, and Project Management teams to support project and client needs.
• Communicate testing results, observations, and issues clearly to stakeholders.

Qualifications

• Bachelor’s or Master’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific field.
• 0–3 years of experience in pharmaceutical, biotech, or CDMO environments.
• Hands-on experience with analytical techniques, including HPLC/UPLC preferred.
• Understanding of cGMP, GDP, and laboratory compliance standards.
• Strong documentation, organizational, and data integrity skills.
• Ability to manage multiple priorities in a fast-paced, client-driven environment.