What are the responsibilities and job description for the QA Specialist/Senior QA Specialist, Deviations position at Evotec?
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 :
Preferred Qualifications :
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.
Salary : $78,000 - $90,000
