Share Email Opening Title Quality Control Data Analyst - Stability Program  About the Organization kaléo is a new type of pharmaceutical company, dedicated to building innovative solutions for serious and life-threatening medical conditions.   Description The Quality Control Data Analyst is responsible for the review, trending (statistical analysis as required), and retention of analytical data as it relates to commercial release, stability, and product development. This person will work directly with various testing suppliers on a daily basis ensuring timely execution of protocols, data integrity, and support internal/external investigations as needed. Additionally, this person will compile and/or review reports for submission to regulatory agencies. Essential Functions: Provide supplier oversight for commercial, stability, and product development testing Perform statistical analysis and identify trends (e.g., out-of-trend (OOT)) in analytical data Establish (where necessary) and revise analytical testing alert limits accordingly Initiate, coordinate, and/or support both internal and external investigations (e.g., out-of-specification (OOS)) Develop, review, and approve analytical testing protocols (drug and device) Critically review analytical testing data reports (drug and device) Maintain data collection tools used for Key Performance Indicator (KPI) tracking Participate in KPI Review Meetings Prepare Statement of Work (SOW) and Purchase Order (PO) with suppliers as necessary Prepare stability sections of Annual Product Reviews (APRs), FDA Annual Reports (ARs), and as required for various regulatory submissions Additional Responsibilities: Act as an additional Subject Matter Expert (SME) for analytical data during regulatory inspections and internal audits Participate as an SME during supplier audits when applicable Develop, review, and approve departmental SOPs Actively participate in QA/QC related initiatives Actively contribute as a member of the QA/QC team   Open Date 3/29/2018   Position Requirements BS Degree in a Life Science, preferably Chemistry Minimum of 5 years quality related experience in biopharmaceutical, parenteral manufacturing, or medical devices preferred, with a minimum of 3 years prior GMP laboratory and/or stability program management Experience using statistical analysis software (e.g., Minitab or SAS JMP) Must possess understanding of CGMPs, FDA and ICH guidance documents related to Stability and data integrity Experience with contract laboratory operations Working knowledge of bacterial endotoxin and sterility requirements for aseptically processed and terminally sterilized products a plus Must work well and coordinate with other departments (e.g., Product Development, Supply Chain, and Regulatory Affairs) Must have the ability to manage multiple priorities/projects, resolve issues, and work in a fast-paced and flexible environment Must possess confidence and be able to communicate with all levels of personnel Must be able to work with external laboratory and manufacturing partners Strong understanding of data analysis tools and root cause analysis Strong oral and written communication skills with the ability to articulate technical information in a clear and concise way   Exempt/Non-Exempt Exempt   Full-Time/Part-Time Full-Time   EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.   Location Corporate   This position is currently not accepting applications. To search for an open position, please go to http://KaleoPharma.appone.com WE ALSO RECOMMEND Other Jobs Within Same Category -- None found -- Other Jobs Within 60 Miles -- None found -- Follow us See who works here:

 

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