Evotec

Manufacturing Compliance Specialist I

Evotec

full-time

Posted on:

Location Type: Hybrid

Location: Redmond • Washington • United States

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Salary

💰 $92,400 - $126,500 per year

About the role

  • 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

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
Benefits
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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
technical problem-solvingtechnical writingGMP complianceCAPA implementationprocess improvementinvestigation techniquessystematic thinkingproject leadershipdata analysisquality assurance
Soft Skills
communicationleadershipteam collaborationdecision-makingaccountabilitytraining and guidancejudgmentissue resolutionorganizational skillsstakeholder engagement