Hybrid Senior Analyst, Contract Manufacturing Quality – Global

at Balchem Corporation

• Job title: Senior Analyst, Contract Manufacturing Quality – Global
• Job type: Full Time
• Experience level: Senior
• Salary: $60,000 - $70,000 per year
• Degree requirement: Bachelor's Degree
• Tech skills: ERP
• Location requirements: Hybrid, Montvale, United States

About the role

• Sr. Analyst overseeing quality management and product safety for comanufacturing at Balchem. Collaborating with cross-functional teams and managing global quality activities.

Responsibilities

• Lead the development, implementation, and governance of the Comanufacturing Quality Management program at Balchem.
• Ensure comanufacturers comply with Balchem Quality Management standards.
• Lead the comanufacturer Quality qualification, approval, onboarding, and ongoing performance management process.
• Act as the primary authority ensuring quality and product safety for global comanufacturing partners, supporting both strategic and tactical activities.
• Manage the co-manufacturer audit program, including conducting audits for qualification or incident investigation.
• Drive visibility of co-manufacturer quality performance through KPI development, tracking, and presentations, as well as continuous improvement activities.
• Support management reviews with data-driven recommendations.
• Manage co-manufacturer change control process for quality- and product safety-related issues.
• Partner with Procurement, R&D, and project teams to support comanufacturing in product innovation projects, acting as the Quality lead for such projects.
• Manage the Quality disposition and release of co-manufactured products.
• Conduct investigations and risk analyses as needed to determine product disposition for OOS material.
• Work with co-manufacturers to identify root causes and ensure the implementation of appropriate and effective CAPAs.
• Conduct regular interactions with co-manufacturers to review quality performance and partner to address issues.

Requirements

• Bachelors degree in Food Science, Regulatory Affairs, Food Law, or a related field.
• Coursework or certifications in areas such as U.S. food regulations, Codex Alimentarius, foreign food regulations, PCQI, and HACCP.
• Minimum of 3 years of experience in food, feed, or dietary supplement quality or regulatory affairs.
• Experience in external manufacturers and/or supplier quality.
• Experience in auditing Quality Management Systems and co-manufacturing/supplier facilities.
• Understanding of Quality and product safety standards (e.g., HACCP, GMP, allergen and contaminant control, GSFI, FAMI-QS).
• Demonstrated problem-solving and root cause analysis skills.
• Strong computer proficiency skills, including word processing, spreadsheet creation, forms development, online research, and ERP usage.
• Strong communication skills, with the ability to clearly and proactively communicate complex data and technical information to internal and external stakeholders.
• Highly detail-oriented, with the ability to assess, interpret, and validate complex information with accuracy.
• Able to work in both office and non-office (i.e., plant) environments as required.
• Able to travel up to ~50%.

Benefits

• Competitive salary and benefits package