Quality Control Compliance Investigator

A brief overview

The Quality Control Compliance Investigator will be responsible for managing Deviations, NCMRs, CAPAs, and OOS investigations within the Quality Control department. This role will also address customer complaints, support the internal audit program, and collaborate closely with the QA and RA departments. Additionally, the position will leverage Quality Management System (QMS) tools to enhance site compliance and drive continuous improvement.

What you will do

• 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

Qualifications

• Bachelor's degree in a science related field
• Minimum 8 years’ experience in a cGMP environment
• 1-3 years’ experience managing Quality Systems
• 1-3 years’ experience with Master Control (preferred)
• 1-3 years of hands on experience in executing quality control analyses (preferred)
• 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.

Base salary range: $82,080 - $112,860

Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training.

Total Rewards

We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.

Corporate Social Responsibility

Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem.

Bachem Americas is an Equal Opportunity Employer

As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status.