Senior Specialist Manufacturing Compliance - Based Redmond, WA
Senior Specialist Manufacturing Compliance - Based Redmond, WA
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Job Description
The Senior Specialist Manufacturing Complianceis 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.
Responsibilities:
- Mentor manufacturing compliance staff
- Drive improvement of 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
- Own metrics related to manufacturing compliance
- 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
- The Specialist will also 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 6 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
- Occasional support and domestic travel as needed (up to 5%)
This job description is intended to describe the general content of the job and to identify the essential functions of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties responsibilities or requirements. Because job requirements evolve with the changing needs of Just-Evotec Biologics business this description is subject to change and may be modified at any time whether formally or informally.
The base pay range for this position at commencement of employment is expected to be $112560 to $154100; 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:
Senior IC
Employment Type
Full-Time
