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This position will have responsibility to support various activities in the Quality Control Laboratory. This includes testing the following sample types R&D, in-process, finished product, stability, as well as raw materials. Job duties may also include assisting in the performance of instrument validations, cleaning validations, and method qualifications as deemed appropriate by management.
Job Responsibility:
Perform routine analytical testing of samples supporting incoming raw materials, in-process production, finished product release, long term stability and validation samples
Assist in deviation investigation, out-of-specification or aberrant results and process changes
Assist in authoring and/or review of GMP documentation including test methods, protocols, reports and raw data
Perform analytical equipment validation, and ensure routine calibration and preventive maintenance is performed at the required intervals with support
Logging and tracking of samples and chemicals
Order chemicals and laboratory supplies as needed
Documents/peer reviews laboratory work using laboratory notebooks/worksheets
May participate in communication between PCI, clients, and analytical testing vendors to support activities including release testing, analytical methods transfer, qualification, validation and implementation
Performs routine data generation and problem solving
Other duties, as assigned.
Requirements:
0-3 years relevant Analytical Chemistry experience, preferably in Quality Control
Bachelor of Science in Analytical Chemistry, Chemistry, Pharmaceutical Sciences or a closely related area of study
General knowledge of analytical techniques using instruments such as: UPLC, HPLC, GC, FTIR, UV/VIS, Karl Fisher, Particle Size Analyzer, Densitometer and Osmometer is preferred
Excellent organizational skills and ability to document technical data
Excellent interpersonal skills and the ability to communicate well orally and in writing to all levels of the organization
Ability to multi-task in a dynamic environment with changing priorities
Must have strong attention to detail, strong problem-solving skills, as well as the ability to work in a cross-functional team environment.