Manufacturing Compliance Specialist I
About The Position
We’re looking for a passionate and curious Manufacturing Compliance Specialist I to join our team. If you’re excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you’ll 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, you'll have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It’s 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.
Requirements
- 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 Associate’s 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
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
Benefits
- Growth Opportunities: We’re a company that believes in continuous learning and development. Whether it’s professional courses, mentorship, or new projects, we’ll 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: We’re committed to building a diverse and inclusive environment where everyone’s voice is valued, and curiosity is encouraged.
- Innovative Projects: You’ll 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 don’t just talk about thinking outside the box—we throw the box away. If you’ve got ideas, we want to hear them.
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
1,001-5,000 employees
