Quality Control Analyst II (3507)

The Position encompasses the analysis of raw materials, in process and finished product testing. This is a first shift position but will be required to work off shifts/weekends to support training of analysts and to support projects and/or production, as required. A candidate must not be allergic to Penicillin and Cephalosporin or their related products and /or materials.
Responsibilities include, but are not limited to, the following:
o Provide routine analytical services using HPLC, FTIR, UV and other typical analytical techniques used for raw materials, in-process and finish products assays o Document and review the completion of testing in Notebooks, Controlled documents, Forms and LIMS and maintain accurate and complete quality records o Follow, understand and comply with client SOP's and policies on cGMP's and safety. Maintain a clean, safe and organized lab area, and potentially assume responsibility to ensure that others maintain their lab areas o Investigate deviations and write exception/OOL/OOS/OOT documents o Will provide validation and qualification support for instrumentation, methods, including, writing and reviewing protocols while maintaining a laboratory notebook
o Support improvement projects and drive efficiency through utilization of LEAN management principles (i/e/ 5S, Kaizens etc) o Work on chemistry laboratory and cross-functional projects. Establish schedules, define dependencies and execute project plans o Proactively and cooperatively communicate with peers and management to ensure awareness of progress and issues; recommend solutions when issues arise o Capable of working independently o Maintain and meet the highest standards in quality, customer service and regulatory compliance o Train new employees/ junior chemists in all aspects of quality control lab o Other projects as assigned
o Bachelors degree in Chemistry or Science related degree with 2-5 years of experience OR Masters degree in Chemistry or Science related degree with 0-3 years of experience o Solid experience with analytical instruments such as HPLC, FTIR, UV, Titrators etc. and wet chemistry techniques o Applicant must have technical skills in troubleshooting instrument issues and aiding in investigations for the Quality Control laboratory o Knowledge of Empower CDS and LIMS is highly desirable o Knowledge of GLP, cGMP requirements and familiar with USP/ICH guidelines is highly desirable o Excellent communication (oral and written) and interpersonal skills o Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude in a highly dynamic environment o Ability to lift up to 50 pound when required o Occasional weekend work required

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