Job Title: Manufacturing Compliance Specialist I
Location: Redmond WA site based some travel to Seattle WA site as required.
Shifts: 40 hours per week Monday to Friday days.
About Us: this is who we are
At Just Evotec Biologics we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team we thrive on challenging the status quo learning from each other and pushing the boundaries of whats possible. Were on a mission to create a place where curiosity isnt just encouragedits celebrated.
Are you someone who asks questions seeks answers and isnt afraid to go deeper #BeCureious with us and see where your curiosity can take you!
The Role: / your challenge in our journey
Were looking for a passionate and curious Manufacturing Compliance Specialist I to join our team. If youre excited by new challenges solving complex problems and learning every step of the way you might just be the perfect this role youll have the opportunity to drive impactful projects collaborate with bright minds and explore uncharted territories.
As a Manufacturing Compliance Specialist I at Just Evotec Biologics youll have the freedom to ask the hard questions think outside the box and find creative solutions that push us forward. Its a role where your curiosity will fuel both your personal growth and the success of the team.
The Manufacturing Compliance Specialist is a crucial role within the Just-Evotec JPOD Manufacturing Site MSAT team responsible for leading deviation investigations and managing Corrective and Preventive Actions (CAPAs) to maintain the highest levels of product quality and regulatory compliance.
What Youll Do:
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
Who You Are:
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 year plus years of experience or an Associates degree and 10 plus years of experience in a GMP manufacturing environment
Previous hands-on experience in a regulated (eg GMP/Aerospace) operations environment
Experience in investigating and helping to resolve production non-conformances implementing CAPA and leading improvement projects
Strong proficiency in Microsoft Word Excel PowerPoint
Familiar with other operations enterprise systems such as DeltaV MES and SAP
Strong leadership organizational communication technical and writing skills
Why Join Us:
Growth Opportunities: Were a company that believes in continuous learning and development. Whether its professional courses mentorship or new projects well help you grow.
Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life. site based role.
Inclusive Culture: Were committed to building a diverse and inclusive environment where everyones voice is valued and curiosity is encouraged.
Innovative Projects: Youll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success.
A Place for Big Ideas: We dont just talk about thinking outside the boxwe throw the box away. If youve got ideas we want to hear them.
Are You Still Curious
If youve read this far then chances are youve got a curious mindjust like us. So what are you waiting for Take the leap and apply today. We cant wait to see where your curiosity leads youand how it will shape the future of Just Evotec Biologics.
Let your curiosity guide your career#BeCurious and explore the endless possibilities at Just Evotec Biologics!
The base pay range for this position at commencement of employment is expected to be $92400 to $126500; Base salary offered may vary depending on the individuals 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.
Required Experience:
IC
Evotec is a global biotechnology company committed to advancing drug discovery & development together with our partners for medicines that matter.