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Capa Manager Jobs in Seattle, WA (NOW HIRING)

Quality Assurance Manager

Redmond, WA · On-site

$120K - $160K/yr

Manage CAPA, deviations, change control, and document control systems * Ensure training compliance and documentation across both functional areas * Support assay validation, method transfer, and fit ...

Manager, Quality

Everett, WA · On-site

$182K - $214K/yr

Own quality execution across the hardware lifecycle, including nonconformance management, MRB, CAPA, supplier quality, root cause analysis, and continuous improvement * Partner with Engineering ...

Quality Assurance Manager

Redmond, WA · On-site

$120K - $160K/yr

Manage CAPA, deviations, change control, and document control systems * Ensure training compliance and documentation across both functional areas * Support assay validation, method transfer, and fit ...

QA MANAGER

Everett, WA · On-site

$100K - $120K/yr

Investigates deviations and uses Root Cause Analysis techniques to complete CAPA (Corrective Action ... people management experience) * Valid Driver's license and ability to travel by air if needed.

Investigates deviations and uses Root Cause Analysis techniques to complete CAPA (Corrective Action ... people management experience) * Valid Driver's license and ability to travel by air if needed.

The PM manages the production environment including engineering, material planning and scheduling ... Expertise in CAPA (Corrective actions and Preventive Plans) to resolve customer field complaints

The PM manages the production environment including engineering, material planning and scheduling ... Expertise in CAPA (Corrective actions and Preventive Plans) to resolve customer field complaints

Lead food safety investigations, root cause analysis, and CAPA programs to prevent recurrence and ... HACCP, PCQI, and/or Certified Food Safety Manager credentials * 7+ years of progressive experience ...

Lead food safety investigations, root cause analysis, and CAPA programs to prevent recurrence and ... HACCP, PCQI, and/or Certified Food Safety Manager credentials * 7+ years of progressive experience ...

Manufacturing Manager

Bothell, WA · On-site

$42.40 - $63.61/hr

The Manufacturing Manager leads safe, quality-focused manufacturing operations while ensuring ... Partner with quality and operational leaders to support CAPA activities, process improvements, and ...

Partner with Quality Management to analyze yield data, identify throughput trends, root-cause failures, and leverage data to implement corrective actions (CAPA). * Serve as a champion for cleanroom ...

We are seeking an experienced Quality Assurance Manager with a strong background in consumer ... Oversee root cause analysis, corrective and preventive actions (CAPA), and continuous improvement ...

Showing results 21-40

Capa Manager information

See Seattle, WA salary details

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$43

$63

How much do capa manager jobs pay per hour?

As of Aug 8, 2026, the average hourly pay for capa manager in Seattle, WA is $43.50, according to ZipRecruiter salary data. Most workers in this role earn between $33.04 and $51.25 per hour, depending on experience, location, and employer.

What does a CAPA manager do?

A CAPA (Corrective and Preventive Action) Manager is responsible for overseeing an organization's CAPA process to ensure compliance with quality and regulatory requirements. They investigate quality issues, identify root causes, and implement corrective and preventive measures to prevent recurrence. CAPA Managers work closely with cross-functional teams to improve processes, maintain regulatory compliance, and enhance overall product or service quality.

What are some common challenges a CAPA manager faces, and how are they typically addressed?

One common challenge CAPA Managers face is ensuring timely and thorough investigations into quality issues while coordinating input from multiple departments. Balancing the need for fast resolution with the rigor required for regulatory compliance can be demanding, especially in highly regulated industries like pharmaceuticals or medical devices. Successful CAPA Managers often address these challenges through clear process documentation, effective project management, and fostering strong collaboration among stakeholders. By leveraging root cause analysis tools and maintaining open communication, they help create a continuous improvement culture that benefits both the organization and its customers.

What are the key skills and qualifications needed to thrive as a CAPA manager?

To thrive as a CAPA Manager (Corrective and Preventive Action Manager), you typically need a background in quality assurance, strong analytical and problem-solving abilities, and experience with regulatory compliance, often supported by a degree in a science or engineering field. Familiarity with quality management systems (QMS), risk management tools, root cause analysis methodologies (such as 5 Whys or Fishbone diagrams), and industry certifications like Six Sigma or ISO 9001 are highly valued. Outstanding candidates demonstrate excellent communication, leadership, and organizational skills to effectively drive cross-functional teams and ensure timely resolution of quality issues. These skills are crucial for identifying, addressing, and preventing compliance gaps or product issues, thereby maintaining high standards and avoiding costly regulatory penalties.

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Quality Assurance Manager

SystImmune, Inc

Redmond, WA • On-site

$120K - $160K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 13 hours ago


Job description

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.
We are seeking an experienced Quality Assurance Manager to support our Translational Science department, which includes both Clinical Pathology and Bioanalytical functions. This role is responsible for ensuring compliance with Bioanalytical Lab QA (GLP/FDA) as well as CLIA/CAP requirements and partnering closely with scientific and laboratory teams to maintain a robust quality system supporting biomarker, IHC, and bioanalytical assay activities.
This is a senior individual contributor QA leadership role with no direct reports. This position is full-time onsite in Redmond, WA and will transition to our new Bothell, WA location in the fall.
Key Responsibilities
  • Maintain and improve the Quality Management System (QMS) in compliance with Bioanalytical Lab QA (GLP/FDA) and CLIA/CAP across Clinical Pathology and Bioanalytical labs
  • Develop, review, and approve SOPs, protocols, and quality documentation
  • Lead FDA inspection readiness and audits for bioanalytical laboratories, including preparation, hosting, and response management
  • Lead internal audits and inspection readiness for CLIA/CAP and external audits
  • Manage CAPA, deviations, change control, and document control systems
  • Ensure training compliance and documentation across both functional areas
  • Support assay validation, method transfer, and fit-for-purpose biomarker and bioanalytical workflows
  • Partner with translational scientists to ensure quality integration across Clinical Pathology and Bioanalytical operations
  • Track and report quality metrics and drive continuous improvement
  • Serve as QA representative during regulatory inspections and client interactions

Qualifications
  • Bachelor's or Master's degree in Life Sciences or related field
  • 7+ years of QA experience in bioanalytical (GLP/FDA) and/or CLIA/CAP laboratory environments
  • Strong knowledge of QMS processes (CAPA, deviation, change control, document control)
  • Experience supporting or leading FDA inspections for bioanalytical labs
  • Experience supporting laboratory audits and inspections
  • Familiarity with clinical pathology, bioanalytical, biomarker, or IHC-based workflows preferred
Preferred Qualifications
  • Experience in CDx, pathology/IHC, or bioanalytical labs
  • Knowledge of GxP environments (GLP/GCP/GMP)
  • Experience with LIMS and electronic QMS systems
  • ASQ certification (e.g., CQA) is a plus
Key Competencies
  • Strong understanding of bioanalytical QA and regulated lab environments
  • Hands-on experience with FDA inspection readiness and audit management
  • Ability to work cross-functionally with scientific and clinical teams
  • Detail-oriented with strong problem-solving and communication skills
Why Join Us
  • High-impact role supporting both Bioanalytical and Clinical Pathology functions within Translational Science
  • Opportunity to lead FDA inspection readiness and regulatory excellence
  • Collaborative, science-driven environment

Compensation and Benefits:
The expected base salary range for this position is $120,000 - $160,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate's level qualifications, experience, and skills.
While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role.
SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.
We offer an opportunity for you to learn and grow while making significant contributions to the company's success.
SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.