Manufacturing Compliance Specialist 1 - Site Based, Redmond, WA

Role Summary

Manufacturing Compliance Specialist I at Just Evotec Biologics (site-based, Redmond, WA) focusing on deviation investigations and CAPAs to maintain product quality and regulatory compliance. This role is part of the JPOD Manufacturing Site MSAT team and involves leading quality improvement efforts, audits, and cross-functional collaboration.

Responsibilities

• Improve the technical capabilities and quality practices within the department
• Coordinate activities and resolve issues across the department, other groups, and/or projects
• Respond to and/or resolve recurring technical or processing issues
• Develop and implement novel approaches to solving non-routine technical problems
• Communicate information effectively through updates, reports, and summaries
• Lead improvements in processes and methods that reinforce cGMP within the department and/or across the site
• Participate directly in internal, external, and global health authority audits/inspections
• Apply systematic thinking processes and technical knowledge to independently address a broad range of non-routine to moderately complex problems
• Conduct investigations, demonstrate strong technical and problem-solving skills, and excellent technical writing skills
• Provide training and guidance on the staff to meet the goals of the department
• When appropriate, assist in providing leadership on project teams
• Represent the department as the SME and lead multi-disciplinary teams or committees
• Provide routine updates on progress, status, and issues associated with campaigns/projects
• Provide support and/or direction to junior staff when necessary
• Exercise sound judgment when making decisions
• Make critical decisions in collaboration with key stakeholders
• Demonstrate accountability for personal, departmental, and organizational initiatives

Qualifications

• BA / BS in a science or engineering related discipline (Biology, Chemistry, Biotechnology, Biochemistry, Biomedical Engineering, Chemical Engineering, Pharmaceutical Manufacturing, Process Engineering) with a minimum 4 years of experience or an Associate‚Äôs degree and 10+ years in a GMP manufacturing environment
• Previous hands-on experience in a regulated operations environment (GMP/Aerospace)
• Experience in investigating and resolving production non-conformances, implementing CAPA, and leading improvement projects
• Strong proficiency in Microsoft Word, Excel, PowerPoint
• Familiar with DeltaV, MES, and SAP
• Strong leadership, organizational, communication, technical and writing skills

Skills

• Problem-solving and technical writing
• Auditing and compliance
• Cross-functional collaboration
• Process improvement and cGMP adherence
• Data analysis and reporting

Education

• BA/BS in a relevant science or engineering field; or an Associate‚Äôs degree with substantial GMP experience

Additional Requirements

• Site-based role in Redmond, WA with some travel to Seattle, WA as required
• 40 hours per week, Monday to Friday, days