Job Description
Position Summary
The Quality Assurance Lead is responsible for coordinating and leading day‑to‑day quality assurance activities on the production floor while supporting the Quality Assurance Supervisor in maintaining compliance with company standards and regulatory requirements. This role acts as a working lead, providing guidance to QA team members, supporting inspections and audits, performing in-process testing, maintaining in-process equipment, and ensuring quality expectations are consistently met.
Essential Duties and Responsibilities
Leadership & Team Support
- Serve as the primary point of contact for QA activities during assigned shifts
- Provide day‑to‑day direction, training, and mentorship to Quality Assurance team members
- Ensure QA coverage and task completion in accordance with priorities set by the QA Supervisor
- Assist in onboarding and training of new Quality Assurance personnel
- Promote a culture of quality, accountability, and continuous improvement
- Perform and oversee inspections, audits, and quality checks of materials, processes, and finished product
- Ensure adherence to quality procedures, work instructions, and specifications
- Review, document, and escalate nonconforming material and quality concerns
- Support containment, root cause analysis, and corrective and preventive actions (CAPA)
- Conduct in-process tablet testing in accordance with approved test methods and specifications
- Perform routine maintenance, cleaning, calibration checks, and basic troubleshooting of in-process equipment to ensure proper operation and data integrity
- Maintain accurate quality records and reports
- Verify documentation is completed correctly and in compliance with internal and external requirements
- Assist the QA Supervisor with audit preparation and responses
- Support compliance with applicable quality standards (e.g., GMP, FDA, customer requirements)
- Document in process testing results and equipment maintenance logs in accordance with data integrity requirements
- Communicate quality expectations and issues clearly to production and operations teams
- Work closely with Production, Engineering, and Supply Chain to resolve quality issues
- Escalate recurring or significant quality risks to the QA Supervisor in a timely manner
- Support customer complaints and investigations as assigned
- Collaborate with Technical and Maintenance teams when in-process testing equipment requires repairs or calibration beyond routine maintenance
- Identify trends, recurring issues, and opportunities for quality improvement
- Assist in developing and implementing process improvements
- Encourage adherence to best practices and standardized processes
- Recommend improvements to in-process testing procedures and in-process equipment maintenance practices
- High school diploma or GED required
- A minimum of 2–5 years ADM manufacturing experience or prior Quality Assurance experience
- Prior lead or senior QA experience preferred
- Working knowledge of quality systems, inspections, and nonconformance processes
- Basic understanding of root cause analysis and CAPA
- Ability to read and interpret specifications, drawings, and procedures
- Proficiency with basic computer applications and quality documentation systems
- Basic understanding of in-process testing methods and safe operation of in-process equipment
- Experience in a manufacturing or regulated environment
- Exposure to GMP, FDA, or other quality standards
- Internal audit experience
- Strong organization, communication, and problem‑solving skills
- Experience with in-process instrumentation or routine in-process equipment maintenance is a plus
- Ability to stand, walk, and move throughout the production environment, use hands to finger, handle or feel objects, tools, or controls, and talk or hear
- Must be able to reach with hands and arms
- Ability to lift up to 35 pounds and move up to 250 pounds using a pallet jack
- Ability to work in a fast‑paced environment
- Flexibility to work varying schedules or overtime as needed
- Use of PPE required
- Attention to detail
- Leadership and teamwork
- Decision‑making and accountability
- Effective communication
- Time management
- Continuous improvement mindset
- Technical accuracy in in-process testing and equipment care
REF:107509BR
