Senior QA Specialist, Supplier Quality

Asahi Kasei

. Assess potential suppliers through reviews of quality systems, manufacturing processes, and capabilities .

Posted 9/16/2026full-timeFremont • California • United StatesSenior💰 $120,000 - $150,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in GMP Quality Assurance and Quality Systems, with a strong understanding of pharmaceutical manufacturing processes and regulatory requirements. Proficient in data analysis, trend analysis, and maintaining effective communication with suppliers and internal teams to drive quality improvements.

Highest-signal resume keywords

GMP Quality AssuranceQuality Systems ExperienceData AnalysisPharmaceutical Manufacturing ProcessesERP and eQMS Systems

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

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

Hard Skills

Quality ManagementChange Control ManagementDiscrepancy ManagementSupplier AuditsQuality Risk ManagementInspection ReadinessRegulatory ComplianceCorrective ActionsMetrics CompilationDocumentation Requirements

Soft Skills

Excellent Communication SkillsEffective Organization SkillsInterpersonal SkillsPlanning SkillsAdaptability

Tools & Technologies

ERP SystemsEQMS SystemsQuality Management Software

Industry Keywords

GMP Regulations21 CFR 210/211/11ANNEX 1ICH GuidelinesSupplier Qualification

Tech Stack

Tools & technologies

ERP

About the role

Key responsibilities & impact

Assess potential suppliers through reviews of quality systems, manufacturing processes, and capabilities
Interface with internal and external suppliers and clients to obtain material and supplier documentation
Establish and maintain quality agreements with suppliers
Perform actions associated with change control documents, discrepancy management, and supplier investigations
Lead and conduct on-site audits at supplier facilities
Identify supplier quality risks and implement mitigation strategies
Maintain communication with suppliers, procurement teams, and internal quality departments to address quality concerns and drive continuous improvement
Enforce quality assurance policies and procedures
Investigate and manage discrepancies affecting product quality, including documentation and corrective actions
Compile metrics for quality management review and communicate disposition status
Coordinate the inspection readiness program
Prepare for and support regulatory agency audits, client audits, and self-inspection
Support management of the supplier qualification, self-inspection, client audit, health authority inspection, and quality management review programs

Requirements

What you’ll need

Bachelor of Science degree or equivalent in a scientific field
Minimum of 10 years GMP Quality Assurance and Quality Systems experience
Experience with ERP systems and eQMS systems is a must
Expertise in data analysis and trend analysis
Strong understanding of pharmaceutical manufacturing processes and documentation requirements
Excellent written and verbal communication skills
Working knowledge of GMP regulations and guidance, including 21 CFR 210/211/11, ANNEX 1, and ICH
Effective organization and planning skills
Demonstrated ability to deal with frequent changes, delays, or unexpected events
Effective interpersonal and communication skills across all management levels and staff
Proficiency with relevant quality management systems and software
Ability to work in a lab/office setting and perform walking, standing, stooping, kneeling, and crouching
Ability to occasionally lift or move up to 15 pounds independently

Benefits

Comp & perks

Hybrid work arrangement
Opportunity to work in a lab/office setting
Equal opportunity employer committed to a diverse workforce