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.
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| Skills: |
- 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.
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