The Quality Specialist QMS, reporting to the Senior Director of Quality Management, will provide support to the Global Quality Systems and Global Supplier Quality Management team by executing assigned day to day activities and supporting continuous improvement activities related to JEB Quality Systems, including but not limited to Deviations/Investigations, CAPA, Change Management, Documents/Records Management and Supplier Quality.
Responsibilities
- Support quality systems continuous improvement activities and ongoing compliance initiatives to promote sustainable compliance.
- Exercise professional written and verbal communication skills in supporting internal customer, supplier, client and team member needs.
- Facilitate the lifecycle of controlled documents in the electronic document management system for global quality systems and global supplier quality documents.
- Review global controlled documents for compliance and adherence to process and system requirements.
- Interface with internal and external suppliers/clients to request/obtain required material and supplier documentation, establish supplier to supplier agreements, and perform general customer inquiries.
- Track and support the initiation, execution, status and documentation of Global Investigations, Global CAPAs and Global Change Controls, Supplier Change Notifications, Supplier Onboarding Requests and Non-Conformance Material Reports.
- Assist in the development of quality system metrics to assess system health and assist in developing and implementing mitigation plans to address any adverse trends observed.
- Support regulatory inspections, internal system audits and client audits.
- Support or process administrative changes to the electronic documentation and quality management systems.
- Participate in site/cross-functional projects, as requested, and represent global quality systems or global supplier quality.
- Execute supplementary GxP activities in support of departmental operations and/or as requested by management.
Qualifications
- Bachelor's Degree in Biochemistry, Biology, Microbiology, Chemistry, or a Scientific/Engineering degree and 3 years plus of relevant quality experience in the biopharmaceutical or medical device industry OR Associate’s degree and 5 years plus of relevant quality experience OR High school diploma / GED and at least 7 years of relevant supplier experience.
- Ability to effectively collaborate and communicate cross-functionally and with external supplier and client personnel.
- Ability to work independently and multi-task in a fast-paced, deadline driven organization.
- Strong organizational skills and attention to detail.
- Knowledge of cGMP regulatory requirements – ICH, FDA, EMA
- Working to advanced use of Office 365 applications, SharePoint and SmartSheet
- Working knowledge of electronic documents and quality management systems (e.g., Veeva, Master Control), LIMS and SAP.
This job description is intended to describe the general content of the job, and to identify the essential functions of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Because job requirements evolve with the changing needs of Just-Evotec Biologics business, this description is subject to change and may be modified at any time, whether formally or informally.
The base pay range for this position at commencement of employment is expected to be $83,000 to $86,250; Base salary offered may vary depending on the individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.
Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.
Top Skills
What We Do
Evotec is a biotechnology company that is committed to advancing drug discovery and development. Through flexible business models, we collaborate with pharmaceutical companies, biotechs, foundations, and government agencies on a substantial scale. We believe that by working together, we can make a difference in the lives of patients.
Our Pipeline Co-Creation model represents our adaptable, multi-modality, fully integrated end-to-end approach to drive collaborations and services across all phases of drug discovery and development – from discovery of novel targets to achieving Proof of Concept in the clinic and into commercial manufacturing.
We aspire to contribute data-driven disease understanding and early disease relevance in humans to bring the probability of success up. We select the right modality, which is then propelled forward on our platforms by our passionate people striving for the fastest and most effective ways towards patient impact. This is enabled by convergence of human ingenuity with data and AI.
We also offer specific solutions, products, and CRO/CDMO-like services, always in support of the Biopharma R&D innovator. Our more than 4,000 scientists work closely with numerous partners concurrently, delivering fully integrated research and development portfolios or individual projects with the highest quality standards and efficiency, coupled with great science, passion, engagement, and communication.
