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Quality Assurance Associate I

  • Anywhere

Company :
Cambridge Isotope Laboratories, Inc.

Location :
Xenia, Ohio

Expiry Date :
Sat, 24 Apr 2021 23:59:59 GMT

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Description :
Cambridge Isotope Separations (CIS) is excited to announce an entry level position for a GMP Quality Assurance (QA) Associate I 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.

Under general supervision, the primary responsibility of the GMP QA Associate I is to work as a team member to ensure and maintain the Companys cGMP (Current Good Manufacturing Practices) compliance.
Responsibilities

* Perform room/line clearances
* Revision and creation of documents, including SOPs and forms
* Issuance, review, and tracking of training forms
* Create/Verify batch records and labels
* Issue/Review/Reconcile logbooks and controlled forms
* Assist with the initiation, tracking and final distribution of approved documents

* Perform any related work as required, based upon experience and training, such as:

Requirements

* Bachelors Degree in chemistry or related science preferred
* Minimum of 0-2 years of experience in a GMP/ISO setting
* Excellent interpersonal, verbal and written communication skills are required
* Attention to detail, organizational skills, ability to multitask and follow tasks through to completion
* Work independently and in a team environment

Benefits

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.