QC Lab TechnicianNew Castle, DE
This role will report directly to the QC Supervisor.
Essential Duties and Responsibilities
- Perform/document required laboratory testing to support in-process, finished product and the stability program. Analytical capabilities and experience must include but are not limited to:
- HPLC analysis – refractive index detection
- Gas Chromatography – Flame ionization detection
- Karl Fischer / Water Content Analysis
- Wet chemistry (titrations, identification tests)
- Physical properties (refractive index, specific gravity)
- Familiar with the USP / EP Pharmacopeia.
- Ensure proper samples are collected and logged. This includes stability samples and study initiation.
- Communicate results to Operations to support the processes.
- Experience with LIMS a plus.
- Initiate and complete OOSI investigations.
- Maintain and revise test methods as needed.
- Notify appropriate personnel when problems arise and work to resolve issues.
- Approve plant cleaning operations.
- Maintain the equipment calibration and maintenance programs
- Maintain the laboratory supply inventory and requisition supplies as needed.
- The ability to work independently with minimal supervision.
- Honesty, integrity, and the ability to work collaboratively, respectfully and safely.
- Effective clear and concise communication.
This position has no direct reports.
Education and/or experience:
- Minimum 4-year chemistry degree or a degree in an applicable science. Individuals with considerable laboratory experience (5 years plus) will be considered.
- Chromatography experience HPLC and GC.
- Good Laboratory techniques with experience in a GMP environment.
- The position is primarily a day shift position, but must be willing to work an extended day (12-14 hrs) two or three times per month. On rare occasions, it's necessary to work a Saturday.
- Previous experience in a multi-tasking work environment.
- Good documentation and communication skills
The position is located at the New Castle, DE Plant.