QA Sr Specialist, Deviations and CAPA

Just-Evotec Biologics is seeking a highly motivated and self-directed Quality professional who desires a significant opportunity to improve worldwide access to biotherapeutics. In this position, you will work as a member of a small highly experienced and innovative team to ensure high quality standards for the safe and reliable production of biological products. The ideal candidate will have significant experience in Quality Assurance activities related to the manufacturing of biological products from Phase 1 to PPQ to commercial. Strong written and verbal communication skills, hands-on execution, and the ability to work with staff across multiple disciplines are essential to be successful in this position.

Responsibilities:

• Manage the QA assessment, review, and approval of investigations of NC/CAPA/Change Control documentation focusing on supporting, IT, Automation, and Manufacturing.
• Support internal and client audits of the quality management systems
• Implement process performance and product quality monitoring programs
• Continue to build and enhance various Quality Assurance programs
• Alert senior management of significant quality, compliance, supply and safety risks

Educational Requirements:

• Bachelors degree in biological or engineering science with 7+ years relevant experience

Preferred Qualifications:

• Industry experience in a fast-paced growing company
• 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, including LIMS, CMMS, MES
• 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

The base pay range for this position at commencement of employment is expected to be $105,000 to $140,000; 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.

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.