QC Associate II

Key Responsibilities

• As part of the QC Phys-Chem Testing team, execute and coordinate routine and non-routine testing of bulk drug substance, final finish products, and raw materials within a multi-product facility.
• Perform laboratory operations independently following appropriate training, including but not limited to: UV-Vis absorbance, QPCR, FTIR and compendial testing.
• Perform essential laboratory support activities such as maintaining inventory of consumables and materials, properly disposing of expired reagents, and identifying and reporting process or equipment anomalies.

Quality, Compliance, and Documentation

• Deliver high-quality analytical results within established timelines, ensuring accuracy right first time.
• Accurately document all work in compliance with cGMP and cGDP requirements.
• Adhere to all site-specific procedures, regulatory standards, and quality systems.
• Promptly and accurately report deviations, abnormalities, or out-of-specification results.
• Maintain strict adherence to safety standards by recognizing and escalating unsafe conditions or behaviors.

Operational Excellence

• Maintain laboratory workspaces in accordance with established 5S and cleanliness standards.
• Ensure personal training is current and compliant with all regulatory and organizational requirements.

• 3-5 years of industry experience
• GMP experience is preferred.
• Technical skills preferred: UV-Vis absorbance, QPCR, and FTIR.

The ideal candidate can demonstrate:

• strong interpersonal and communication skills (both written and oral)
• strong customer focus, and an ability to interact with various departments and levels.
• ability to work independently and as part of a team, to meet departmental/facility goals
• able to work across functions to achieve common goals.
• strong attention to detail, and an ability to focus on details of execution.

Bachelors' degree in Biology or Life Sciences required