Bachem · 21 hours ago
QC Compliance Investigator
Vista, CA
Full-time
Onsite
Senior Level, Lead/Staff
$90K/yr - $123K/yr
8+ years expBachem is a company focused on quality control in the pharmaceutical industry, and they are seeking a QC Compliance Investigator. This role involves managing deviations, nonconformance reports, and investigations to ensure compliance with regulatory standards and continuous improvement within the Quality Control department.
Chemical
Responsibilities
Lead problem resolution and GMP compliance by driving root‑cause investigations, managing the Corrective and Preventive Action (CAPA) lifecycle, and ensuring timely closure of deviations, nonconformances, and out‑of‑specification (OOS) results
Own trending and analysis of key quality records—including Deviations, Nonconforming Material Reports (NCMRs), CAPAs, OOS results, and customer complaints—to identify systemic issues and drive continuous improvement
Align QC with site‑wide and global quality initiatives, aligning solutions with regulatory requirements and internal standards; identify process gaps, facilitate root‑cause analysis, and implement effective CAPAs to improve operational efficiency, product quality, and audit readiness
Develop, monitor, and present Quality Metrics for Quality Management Reviews (QMR), ensuring accurate tracking, trend analysis, and clear communication to leadership to assess system health and prioritize improvements
Maintain a constant state of audit readiness, prepare documentation, host internal and external audits, and deliver timely, thorough responses to findings to sustain continuous compliance
Interpret and apply FDA, USP, and ISO requirements, translating complex regulations into clear, actionable procedures and practical workflows that reflect current expectations and industry best practices
Provide input on complex quality decisions, including change control, CAPAs, and deviations; evaluate compliance, risk, and product quality impact to ensure robust decision‑making
Serve as Subject Matter Expert (SME) for Quality Control Systems for the QC group, offering strategic guidance and regulatory interpretation to ensure consistent, compliant execution of quality processes
Author and revise Standard Operating Procedures (SOPs) and product specifications, ensuring clarity, regulatory compliance, and alignment with current operational practices; maintain controlled documentation to support continuous improvement
Qualification
Required
Bachelor's degree in a science related field
Minimum 8 years' experience in a cGMP environment
1-3 years' experience managing Quality Systems
Strong ability to critically assess SOPs, investigations, and project protocols for regulatory compliance
Proficient in preparing internal reports, technical content, and data summaries with sound conclusions
In-depth knowledge of cGMPs, 21 CFR Parts 210 and 211, ICH Q7, and USP–NF standards
Solid understanding of risk management principles and their application in quality systems
Advanced Excel skills, including the ability to create charts and graphs for data visualization
Excellent written and verbal communication skills; able to work effectively in team environments
Proficient in Microsoft Office applications, including Word, Excel, and PowerPoint
Strong organizational and multitasking abilities; thrives in fast-paced, deadline-driven settings
Capable of influencing and managing projects in a cross-functional, matrixed environment
Proactive, solution-oriented communicator with strong attention to detail and problem-solving skills
Able to work independently, manage time effectively, and troubleshoot technical issues as needed
Preferred
1-3 years' experience with Master Control
1-3 years of hands on experience in executing quality control analyses
Benefits
Competitive pay
Annual performance bonus
A generous benefit package with comprehensive Medical/Dental/Vision coverage
401(k) plan with employer contribution
Paid vacation
Personal and sick days
Company
Bachem
Bachem Holding AG is an independent, technology-based, public biochemicals company.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Pascal Degen
Vice President Global Supply Chain Management
Anne-Kathrin Stoller
President Bachem Americas
Recent News
2025-11-01
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2025-10-31
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