Job Description

　　Our mission is to provide innovative solutions to support viral, genetic, and cell-based therapies in order to improve patient quality of life worldwide. We are a leading provider of viral and cellular products and research services with a focus on viro-immunotherapies. Imanis also provides correlative testing for clients who perform oncolytic virus clinical.

　　We are currently seeking a proactive, reliable, and experienced quality assurance specialist with outstanding interpersonal and technical skills. Interested candidates should have GxP and/or Clinical Laboratory Improvement Amendments (CLIA) experience.

　　Employment Type:

　　Full time

　　Key Responsibilities:

　　* Facilitate QA Strategy implementation, delegated GxP inspection readiness efforts, providing Quality Assurance Unit support as described in 21 CFR Part 58, providing metrics tracking and reporting.

　　* Perform audits on raw data and final reports to assure accuracy and compliance with GxP, study protocols, and laboratory procedures.

　　* Monitor laboratory quality assurance activities to determine conformance with authorized policies and procedures and with sound practice.

　　* Review all documentation for adherence to organizational quality standards.

　　* Ensure that facilities, equipment, organization, processes, and procedures comply with applicable regulations and company standards.

　　* Provide QA support of change controls, deviations, investigations, CAPA's and effectiveness checks.

　　* Develop and maintain compliance-related trending metrics and reports.

　　* Makes appropriate recommendations for correction and improvement as may be necessary.

　　* Provide oversight of personnel training record management.

　　* Provide QA support of internal and external audits, as assigned.

　　* Reviews and updates Quality Assurance procedures.

　　* Maintains audit forms and QA records.

　　* Other duties as needed.

　　Skills and Requirements

　　Qualifications:

　　* Bachelor's degree in quality assurance or science-related field.

　　* Minimum of 5 years in GxP or equivalent regulatory environment.

　　* Excellent knowledge of GLP and GCP requirements.

　　* Working knowledge of ISO 9001, ISO 17025, and ISO 17034.

　　* Experience with reviewing laboratory data and computer validated data collection systems in a preclinical and clinical environment.

　　* Able to understand published methodology to audit existing test methods and ensure accuracy.

　　* Thorough understanding of governing regulations and pertinent scientific literature to ensure compliance.

　　* Experience performing quality process audits and review of deviations and CAPA.

　　* Solid working knowledge of Microsoft Office software (e.g., Excel, Word, PowerPoint).

　　* Possess excellent time and project management skills, being able to manage and prioritize multiple tasks under strict deadlines with minimal supervision.

　　* Possess excellent interpersonal skills, being able to consult and work with multi-disciplined teams.

　　* Possess excellent verbal and written communication skills, including the ability to understand and verify scientific text and data.

　　* Background in molecular biology, virology and/or serology is a plus.

　　* Contract research organization (CRO) experience is a plus.

　　* Experience with eQMS (Qualio) is a plus. null

　　We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].