QA Specialist, Quality Management Systems (QMS)-Change Control – J-POD Redmond Facility
Just-Evotec Biologics is seeking a highly motivated and self-directed Quality professional who desires a significant opportunity to improve worldwide access to biotherapeutics. This role is responsible for the execution of day-to-day QA responsibilities for GMP manufacturing, along with building and enhancing the quality assurance systems. The role incumbent works both independently and collaboratively with Manufacturing, Quality and Facilities staff to ensure compliance with cGMPs and internal procedures. The responsibilities of the employee is based on the assigned QA organization as outlined below.
Responsibilities:
- Review and assess all quality events of eQMS (Deviations, Change Control, CAPA, Risk Assessment, Management Review, Complaint Investigation, Product Quality Review etc.) to assure compliance with regulatory and Just-Evotec Global Quality Management Systems (G-QMS) requirements.
- Provide inputs and reviews on communication as to the status of deliverables to customers, management, and stakeholders.
- Develop, review, and deliver training regarding QMS process or system changes.
- Support QA QMS in internal and external client audits and regulatory inspections (including but not limited to SME for QMS processes and individual records).
- Monitor and review effectiveness for QMS through trending, analysis, and metrics; report to top management and G-QMS on the performance of the KPIs and identify opportunities for continuous improvement.
Educational Requirements:
- Bachelors degree in biological or engineering science with 5+ years relevant experience in industry and a minimum of 3 years relevant experience in a biopharmaceutical/Pharmaceutical cGMP manufacturing or similar environment.
Preferred Qualifications:
- Ability to collaborate and communicate cross-functionally.
- Proven attention to detail
- Industry experience in a fast-paced growing company with Quality working experience with root cause analysis tools, Deviation / CAPA and Change Control.
- Quality or other working experience with plant facilities, equipment, and critical utilities
- Quality working experience with drafting, reviewing, and approving Standard Operating Procedures.
- Critical thinker with a comprehensive understanding of biologics regulatory requirements
- Risk management principles, and science-based decision making
- Expertise in tools, concepts, and methodologies of QA
- Strong computer skills including Microsoft Office and eQMS databases.
- Preferred experience in Compliance Quest and Veeva eQMS
- Key competencies in verbal and written communication; attention to detail; data collection
- Management, and analysis; judgement and decision making; and building teams
- Experience working with IT in a GMP environment
- Experience in creating quarterly reports, metrics, QMR and audit/inspection support
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 $78,000 to $90,000; Base salary offered may vary depending on individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision and 401k company match, flexible 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.
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.
