Quality Assurance Specialist Jobs

About The Position

Requirements

• Bachelor’s degree in Life Sciences or Engineering.
• At least 7 years of experience in Quality functions within life sciences or a closely related industry.
• At least 1 year of experience managing projects and priorities in a complex matrix organization.
• Written communication skills sufficient to produce approver-level records and clear disposition or approval rationales.
• Verbal communication skills to lead discussions toward decisions under tension and clearly frame risk and impact for stakeholders.
• Digital communication skills to standardize decision-support visuals, such as Pareto charts and trend analyses where applicable, and coach others on effective data storytelling.
• Must be legally authorized to work in the United States without restriction.
• Must be willing to take a drug test and post-offer physical if required.
• Must be at least 18 years of age.

Nice To Haves

• Advanced degree.
• Experience leading readiness and defense activities for client and regulatory audits within assigned scope.
• Experience contributing to cross-site alignment and benchmarking of Quality Assurance practices.

Responsibilities

• Execute assigned quality tasks, including authoring, performing, and reviewing work in accordance with GxP procedures and company compliance requirements.
• When assigned, interface with clients, contract manufacturing organizations, contract laboratory organizations, and suppliers to build partnerships, defend the Quality System, and negotiate solutions supporting patient safety, regulatory compliance, and Quality Agreements.
• Act as the quality responsible person and first escalation point, providing quality guidance to resolve issues.
• Establish, maintain, and sign Quality Agreements in accordance with company SOPs and signature policies.
• Own deviation and change-control records and ensure timely completion of associated training.
• Prepare and review SOPs, work instructions, investigational and validation protocols, templates, plans, and Quality Agreements.
• Serve as delegated responsible person for product release when assigned.
• Own or support implementation of the Batch Disposition quality system, oversee documentation readiness and batch-record quality, and act as deputy for site disposition governance.
• Allow, endorse, or approve activities, assessments, documents, and procedural updates in accordance with company governance and GxP regulations.
• Approve or review key GMP records, including master and executed batch records, change controls, investigations, discrepancy risk assessments, complaints, annual product reviews, supplier qualifications, and extension requests.
• Maintain shopfloor presence during GMP operations to verify SOP compliance, data integrity practices, cleanroom behaviors, and identification of operational risks, including for outsourced activities.
• Suspend GxP operations when warranted, direct remediation, resolve critical issues, and escalate according to severity.
• Collect, assess, trend, evaluate, and report data in accordance with area SOPs, including annual or periodic quality reviews, failure trending, and KPI preparation.
• Serve as a subject matter expert and local management system owner; remain trained and knowledgeable about applicable local and global procedures.
• As system owner, design, establish, maintain, and implement global systems; develop KPIs; improve processes; identify, evaluate, and mitigate risks; and benchmark performance across company sites.
• Conduct trend analyses and escalations, introduce system corrections and improvements, and provide status updates to site review forums, including senior leadership.
• Drive Fremont site integration into global platforms, represent site needs in global forums, and influence global and divisional management system owners to establish practical procedures.
• Identify, share, and adopt best practices across company sites, and support continuous improvement systems and processes.
• Partner with Manufacturing to identify process gaps, provide on-the-spot coaching, and improve compliance and quality culture.
• Prepare regulatory submission documentation, support audit readiness, assist during inspections, and represent the Fremont site by defending site practices and decisions.
• Lead difficult stakeholder conversations, manage supplier or client quality topics as assigned, and coach across teams to improve performance.
• Lead cross-functional continuous improvement initiatives with measurable outcomes.
• Own significant portions of the Quality Management System, identify systemic risks, and lead audit and inspection defense for the assigned area.
• Partner on validation strategy, reduce technology-transfer risks, anticipate failure modes such as through FMEA, and ensure trend and report evaluations drive durable CAPAs and governance inputs.

Benefits

• Competitive compensation and benefit programs
• Support for a healthy working environment, meaningful work, mobility, networking, and work-life balance