Quality Control Group Leader
Cambridge Isotope Laboratories, Inc.
Expiry Date :
Sat, 24 Apr 2021 23:59:59 GMT
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Cambridge Isotope Separations (CIS) is pleased to announce a unique opportunity for a Quality Control (QC) Group Leader located in Xenia, Ohio. CIS is the world leader in the separation of stable isotopes and related chemistry. CIS and its parent, Cambridge Isotope Laboratories (CIL) in Massachusetts, are subsidiaries of the Otsuka Pharmaceutical Group. CIL separates both 13C and 18O at its Xenia, Ohio, facility and operates the only large capacity nongovernmental Deuterium Oxide enrichment columns in the world. We globally support a broad range of customers across many high-tech industries including pharmaceutical, semiconductor, medical diagnostic, display and basic research. We are rapidly expanding, and the Ohio facility is an integral part of our growth for the future.
The QC Group Leader supports the QA/QC Manager by overseeing the daily work of the QC Chemists directly. This includes, but is not limited to: scheduling and prioritization of routine samples and work assignments, review of data folders, performance of routine equipment maintenance, being the primary point of contact for the department manager and external departments regarding the status of daily work flow, and responding to procedural and routine technical questions from QC Chemists. The QC Group Leader may also perform the role of QC Chemist, conducting analysis of raw materials, in-process and finished GMP and non-GMP products according to standard operating procedures (SOPs).
* Responsible for the scheduling and performing of tests and/or calibrations and evaluations or results related to GMP, ISO and non-GMP materials and products
* Supervise, prioritize and schedule daily laboratory activities
* Ensure training and development for QC team and relevant production staff performing analytical testing and sampling
* Review and approve testing data from external service suppliers, such as outsourcing laboratories
* Performs relevant trend analysis and instrumentation performance
* Leads site QC team in relation to quality management system responsibilities for QC including but not limited to, CAPAs, deviations, OOSs, validations
* Lead site activities with regards to analytical instrument selection and qualification activities including, but not limited to, Gage R&R and Measurement System Analysis (MSA)
* Document test data as required
* Utilize the following techniques to characterize organic and inorganic chemicals: NMR, MS, GC, wet chemistry tests, densitometer, conductivity, etc.
* Write and update procedures and protocols as required
* Supports customer complaint investigations
* Supports continuous improvement projects
* Performs any related work as required, including performing QC tests
* BS/MS degree in Chemistry or related field plus a minimum of 5 years of industry QC lab experience; GMP experience preferred
* Prior experience as a team lead or supervisor of others is required
* Experience is analytical instrument installation and qualification is required
* Excellent interpersonal, verbal and written communication skills are required
* Knowledge and/or experience with ISO 9001, current Good Manufacturing Practices, or ICH Q7 is preferred
* Experience with Six Sigma and/or Measurement System Analysis is preferred
* Attention to detail, organizational skills, ability to multitask and follow tasks through to completion
* Work independently and in a team environment
CIS offers a competitive salary and a comprehensive benefit program including generous paid time off, health insurance with 100% company paid deductibles, Long Term Incentives and 6% matching 401K plan.
CIS is an EEO/Affirmative Action employer.