Manufacturing Compliance Specialist

Jobtailor; Redmond (WA); On-site; USD 90,000 - 120,000; Full time

Job summary

Jobtailor seeks an experienced Quality Assurance professional in Redmond, WA to lead deviation investigations and ensure cGMP compliance across manufacturing operations. You will analyze CAPAs, support audits, and collaborate with cross-functional teams to drive continuous improvements and maintain data integrity in a regulated environment.

Strong technical writing and risk management skills are required, and you will mentor junior staff while preparing reports for internal and regulatory

Qualifications

• Bachelor/BS in science or engineering.
• 1
• 4–6 years GMP manufacturing experience, or Associate’s degree with 10+ years.

Responsibilities

• Lead deviation investigations and root cause analyses.
• Support compliance documentation and investigations with strong writing.
• Drive continuous improvements to reinforce cGMP standards.
• Partner with cross-functional teams to implement CAPAs.
• Analyze deviations, CAPAs, and metrics to spot trends.
• Prepare updates and reports for audits and inspections.

Skills

Root Cause Analysis

Deviation Investigation

Data Analysis

Technical Writing

Process Improvement

Leadership

Communication

Organizational Skills

Judgment

Collaboration

Education

BA/BS in science or engineering

Associate’s degree + 10 years GMP experience

Tools

Veeva

TrackWise

MasterControl

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

• 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

• 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.

Core Competencies

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 Experience
• CAPA Implementation
• Technical Problem-Solving
• CGMP Regulations Knowledge
• Electronic Quality Management Systems (eQMS)

ATS Optimization Keywords

Hard Skills

• Root Cause Analysis
• Deviation Investigation
• Data Analysis
• Technical Writing
• Process Improvement

Soft Skills

• Leadership
• Communication
• Organizational Skills
• Judgment
• Collaboration

Industry Keywords

• CGMP
• FDA Regulations
• ICH Guidelines
• Quality Risk Management
• Data Integrity Principles

Tools & Technologies

• Microsoft Word
• Microsoft Excel
• Microsoft PowerPoint
• Veeva
• TrackWise
• MasterControl