Manufacturing Compliance Specialist

Evotec

Manufacturing Compliance Specialist resolving quality issues at Evotec. Driving compliance with regulations and leading investigations to ensure product quality in Redmond, WA.

Posted 7/23/2026full-timeRedmond • Washington • 🇺🇸 United StatesMid-LevelSenior💰 $92,400 - $126,500 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates strong technical problem-solving and writing skills to support compliance documentation and investigations, while driving continuous improvements in processes that reinforce cGMP standards. Possesses extensive experience in investigating deviations, implementing CAPAs, and collaborating with cross-functional teams to enhance quality and compliance.

Highest-signal resume keywords

GMP Manufacturing ExperienceCAPA ImplementationTechnical Problem-SolvingCGMP Regulations KnowledgeElectronic Quality Management Systems (eQMS)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Root Cause AnalysisDeviation InvestigationData AnalysisTechnical WritingProcess Improvement

Soft Skills

LeadershipCommunicationOrganizational SkillsJudgmentCollaboration

Tools & Technologies

Microsoft WordMicrosoft ExcelMicrosoft PowerPointVeevaTrackWiseMasterControl

Industry Keywords

CGMPFDA RegulationsICH GuidelinesQuality Risk ManagementData Integrity Principles

About the role

Key responsibilities & impact

Lead deviation investigations and root cause analyses to identify, document, and resolve manufacturing and quality events.
Demonstrate strong technical problem-solving capabilities and excellent technical writing skills to support compliance documentation and investigations.
Drive continuous improvements in processes and methods that reinforce cGMP within the department and/or across the site
Partner with cross-functional stakeholders to identify, develop, and implement effective Corrective and Preventive Actions (CAPAs) that prevent recurrence of deviations and address underlying issues.
Analyze and trend deviations, CAPAs, and compliance metrics to identify recurring issues, emerging risks, and opportunities for improvement.
Develop and implement novel approaches to solving non-routine technical and compliance challenges.
Communicate information effectively through updates, reports, and summaries.
Support and participate in internal audits, client audits, and regulatory inspections conducted by global health authorities.
Apply systematic thinking processes and technical knowledge to independently address a broad range of non-routine to moderately complex problems
Collaborate with operational teams to implement process improvements while maintaining regulatory compliance.
Support GMP training or knowledge sharing initiatives to foster a culture of quality, compliance, and continuous improvement.
Provide routine updates on campaign, project, and investigation status, including risks, challenges, and mitigation plans.
Provide support and/or direction to junior staff when necessary
Exercise sound judgment and make data-driven decisions within established quality and compliance frameworks.
Make critical decisions in collaboration with key stakeholders
Demonstrate accountability for personal, departmental, and organizational initiatives.

Requirements

What you’ll need

BA / BS in a science or engineering related discipline (Biology, Chemistry, Biotechnology, Biochemistry, Biomedical Engineering, Chemical Engineering, Pharmaceutical Manufacturing, Process Engineering)
minimum 4-6 years of experience or an Associate’s degree and a minimum of 10 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/Change Controls and leading improvement projects
Strong proficiency in Microsoft Word, Excel, PowerPoint
Familiarity with electronic quality management systems (eQMS) such as Veeva, TrackWise, MasterControl, or similar platforms.
Strong knowledge of cGMP regulations, FDA regulations, ICH guidelines, data integrity principles, and quality risk management practices.
Strong leadership, organizational, communication, technical and writing skills.

Benefits

Comp & perks

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