Sr. QA Specialist, Supplier Quality

Bionova Scientific LLC; Fremont (CA); Hybrid; USD 120,000 - 150,000; Full time

Job summary

Bionova Scientific LLC is seeking a Sr. QA Specialist, Supplier Quality to lead supplier qualification, audits, and QA compliance programs in Fremont, CA.

The role focuses on GMP practices, supplier documentation, and quality agreement management, with cross-functional collaboration across procurement and QA teams. The ideal candidate has a BS in a science field and 10+ years of GMP QA experience, including ERP/eQMS proficiency and strong data analysis.

Qualifications

• Bachelor of Science in a scientific field required.
• Minimum 10 years GMP QA and Quality Systems experience.
• Experience with ERP and eQMS systems required.
• Strong data/trend analysis skills.
• Excellent written and verbal communication.
• Knowledge of GMP regulations (21 CFR 210/211/11, ANNEX 1, ICH, etc.).

Responsibilities

• Assess potential suppliers through reviews of quality systems, processes and capabilities.
• Interface with internal/external suppliers and clients to obtain documentation and establish quality agreements.
• Negotiate and maintain quality agreements outlining product specs, QC procedures and reporting.
• Handle Change Control activities, discrepancy management and supplier investigations.
• Lead on-site supplier facility audits to verify GMP compliance and documented procedures.
• Identify quality risks and implement mitigation strategies with suppliers.
• Coordinate communications with suppliers, procurement and internal QA teams.
• Enforce QA policies to maintain product quality and compliance.
• Investigate discrepancies and manage corrective actions and CAPA.
• Compile metrics for Quality Management Review and report disposition status.
• Coordinate inspection readiness and support regulatory audits and self-inspections.

Skills

GMP Quality Assurance

Supplier Quality

Data Analysis

Documentation & Reporting

Communication Skills

Independent & Teamwork

Education

BS in Science

Tools

ERP Systems

eQMS

QMS Software

Microsoft Office

Job description

This Sr. QA Specialist, Supplier Quality is part of the Quality Assurance Compliance team. As a member of the QA team, the role incumbent has GMP Quality experience assessing supplier's compliance and managing the Bionova Scientific's (BNS) supplier qualification program. The role also supports Bionova Scientific's self-inspection program, as well as management of the client audits, health authority inspections, and quality management review. The position requires a high attention to detail, to be organized in their work, strong written and verbal communication skills and working well independently and in a team environment.Location Fremont, CAHybrid - 3-4 days in office a weekPosition Responsibilities:Assessing potential suppliers through thorough reviews of their quality systems, manufacturing processes, and capabilities to ensure they meet required quality standardsInterface with internal and external suppliers/clients to request/obtain required material and supplier documentation, establish quality agreements as applicable, etc…Negotiating and maintaining quality agreements with suppliers, outlining expectations regarding product specifications, quality control procedures, and reporting requirementsPerform actions associated with Change Control documents, discrepancy management and supplier investigationsLeading and conducting regular on-site audits at supplier facilities to verify compliance with established Bionova quality requirements, GMP practices, and documented proceduresIdentifying potential quality risks associated with suppliers and implementing mitigation strategies to minimize risks to product qualityMaintaining open communication with suppliers, procurement teams, and internal quality departments to address quality concerns and drive continuous improvementEnforce quality assurance policies and procedures to maintain product quality and complianceInvestigating and managing discrepancies that may impact product quality, ensuring proper documentation and corrective actions are takenCompile metrics for presentation for quality management review and communicate disposition status in a timely mannerCoordinate the inspection readiness program for Bionova ScientificPreparing for and supporting regulatory agency audits, client audits and self-inspectionWorking Conditions:This position requires work in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 15 pounds independently.Qualifications:Bachelor of Science degree or equivalent in a scientific fieldMinimum of 10 years GMP Quality Assurance and Quality Systems experienceExperience with ERP systems and eQMS systems is a mustExpertise in data analysis, trend analysisStrong understanding of pharmaceutical manufacturing processes and documentation requirementExcellent written and verbal communication skills to effectively document findings and present technical informationWorking knowledge of GMP regulations and guidance (21 CFR 210/211/11, ANNEX 1, ICH, etc.)Effective organization and planning skills. Demonstrated ability to deal with frequent changes, delays, or unexpected eventsEffective interpersonal and communication skills. Communication at all management levels and all staff is requiredProficiency with relevant quality management systems and softwareThe base compensation range for this role is $120,000-$150,000. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.#LI-MG1#Hybrid