23 Sep
QC Analyst
Colorado, Frederick , 80530 Frederick USA

Vacancy expired!

Please note that this is a 6 months contract position. Conducts routine and non-routine analysis and reviews of analytical data for cleaning validation support studies and other requested testing according to Standard Operating Procedures (SOP) and Analytical Methods in accordance with current Good Manufacturing Practices (cGMPs) and regulatory requirements. Completes projects with supervision. Has a clear understanding of Good Laboratory Practices (GLPs), cGMPS, and other regulatory requirements. Actively engages in continuous improvement of processes and procedures. Proven ability to exercise judgment and appropriately escalates issues to Validation management.ESSENTIAL DUTIES AND RESPONSIBILITIES:Outstanding communication skills, both written and oral, and will be expected to communicate directly with project managers and management.Prepares buffers, reagents and product samples for testing in support of the cleaning validation program.Calculates maximum allowable carryover values for cleaning program.Maintains laboratory notebooks, laboratory equipment, and monitors supplies.Reviews data for compliance to specifications, and reports and troubleshoots abnormalities.Required to follow good documentation practices.Works cross-functionally to complete projects and testingQualificationsBachelor's degree (B.S.) or equivalent experience in Analytical Chemistry or related life sciences field2+ years industry experience and/or training; or equivalent combination of education and experience.Proven knowledge of cGMP guidelines as well as international regulations (i.e., International Committee on Harmonization (ICH) Q7) pertaining to Quality Control programs that support the production of APIs, stability and drug product release.Previous experience with UV-Vis, pH/conductivity, gravimetric analysis, oligos, and cleaning coupon studies a plus.Knowledge of FDA regulations and guidelinesProven skills in coordinating and managing day to day tasks and working in collaboration to accomplish deadlines and objectivesPersonal leadership skills and fosters working in a team environmentKnowledge of and skills in using computer software and hardware applications, including Microsoft Word and ExcelApplicants must provide their phone number. Reference job number A863.

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