Quality Assurance Lead

We are looking for a Quality Assurance Leader to join the team! This is a full-time, direct position in a developer and manufacturing facility in the Columbus, IN area.

The Quality Assurance (QA) Lead supports the QA Manager by ensuring safety, sanitation, and regulatory compliance across the facility. This role supervises QA Technicians, manages day-to-day QA functions, and serves as Preventive Controls Qualified Individual (PCQI). The position is hands-on in the laboratory and production areas, ensuring quality systems are implemented, verified, and continuously improved.

Responsibilities:

Food Safety

• Serve as PCQI, signing off on production documentation and product release.
• Coordinate finished goods release, ensuring test results, documentation, and Certificates of Analysis/Compliance are accurate and timely.
• Manage Quality Management Systems (QMS) including Hazard Analysis Critical Control Point (HACCP), Good Manufacturing Practices (GMPs), Pest Control, Allergen Control, Master Sanitation System (MSS), Environmental Monitoring Program (EMP), Internal Audits, Label Verification.
• Maintain food safety certifications and compliance programs, such as SQF, Gluten-Free, Rainforest Alliance, Organic, Kosher.
• Oversee third-party testing, environmental monitoring, and equipment verification, addressing deviations promptly.

Laboratory Leadership

• Direct and coordinate daily QA lab testing priorities to support production and customer ship dates.
• Perform or oversee product testing (moisture, allergens, microbiological) and data entry into ERP system INFOR.
• Ensure lab equipment is calibrated, and supplies are maintained.
• Act as point of contact for external labs and suppliers.

Continuous Improvement & Communication

• Interact with clients regarding complaints and resolutions and manage the Corrective Action Reporting (CAR) program.
• Track and report QA metrics (Key Performance Indicators, CARs, audit items), identifying trends and initiating proactive corrections.
• Lead internal audits, follow up on findings, and verify corrective actions through closure.
• Serve as QA liaison between QA and Operations, maintaining alignment across shifts and communicating priorities in real time.
• Train, coach, and validate competency of QA Technicians through process validations and ongoing skill verification.
• Write, revise, and maintain Standard Operating Procedures (SOPs), Sanitation Standard Operating Procedures (SSOPs), and controlled documents or oversee product testing (moisture, allergens, microbiological) and data entry into ERP system INFOR.
• Ensure all areas of plant are audit-ready.

Requirements:

• High school diploma required.
• Bachelor’s degree in Food Science, Chemistry, Biology, or related field preferred.
• A minimum of 3 years of QA experience in a food production or pharmaceutical environment.
• Knowledge of Current Good Manufacturing Practices (cGMPs) and regulatory requirements.
• HACCP and PCQI certified.
• Excellent math, organizational, and time-management skills.
• Proficiency in Microsoft Excel, Word, Outlook, and AI tools.
• Excellent written and verbal communication skills.
• Demonstrated leadership ability with experience supervising employees.
• Ability to manage multiple priorities and make sound decisions under pressure.

Details:

• This is a full-time, direct position in a developer and manufacturing facility in the Columbus, IN area.
• Position: Quality Assurance Leader
• Schedule: Monday - Friday; 7:30 am - 4:00 pm
• Salary: negotiable; based on experience with full benefits.
• This is a W-2 position. No B2C/C2C. No sponsorship.

Malone is an Equal Opportunity Employer.