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Quality Assurance Manufacturing Specialist
2 months ago
The Quality Assurance Manufacturing Specialist plays a vital role within the Just-Evotec Biologics MSAT team, focusing on leading investigations into deviations and overseeing Corrective and Preventive Actions (CAPAs) to ensure exceptional product quality and adherence to regulatory standards.
Key Responsibilities:
- Enhance the technical skills and quality protocols within the team.
- Facilitate coordination and resolution of issues across various departments and projects.
- Address and resolve recurring technical or processing challenges.
- Innovate and implement unique solutions for complex technical issues.
- Effectively communicate updates, reports, and summaries to stakeholders.
- Drive process improvements that uphold current Good Manufacturing Practices (cGMP) within the team and across the organization.
- Engage in internal, external, and global health authority audits and inspections.
- Utilize systematic thinking and technical expertise to tackle a wide range of complex problems independently.
- Conduct thorough investigations, showcasing strong technical and analytical skills, along with excellent writing capabilities.
- Provide training and mentorship to staff to achieve departmental objectives.
- When necessary, offer leadership on project teams.
- Act as the Subject Matter Expert (SME) for the department and lead cross-functional teams or committees.
- Deliver regular updates on progress, status, and challenges related to projects.
- Support and guide junior staff as needed.
- Exercise sound judgment in decision-making processes.
- Collaborate with key stakeholders to make critical decisions.
- Demonstrate accountability for personal, departmental, and organizational goals.
- Bachelor's degree in a scientific or engineering discipline (e.g., Biology, Chemistry, Biotechnology, Biochemistry, Biomedical Engineering, Chemical Engineering, Pharmaceutical Manufacturing, Process Engineering) with 0-2 years of experience in a GMP manufacturing setting.
- Hands-on experience in a regulated operations environment (e.g., GMP/Aerospace).
- Experience in investigating and resolving production non-conformances, implementing CAPA, and leading improvement initiatives.
- Proficient in Microsoft Word, Excel, and PowerPoint.
- Familiarity with operational enterprise systems such as DeltaV, MES, and SAP.
- Strong leadership, organizational, communication, technical, and writing skills.
Just-Evotec Biologics is an Equal Opportunity Employer. All qualified candidates will be considered for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.