Lead Quality Assurance Technician

Lead Quality Assurance Technician

As a Lead Quality Assurance Technician, you will perform in-process and finished product inspections across manufacturing lines to ensure compliance with cGMP, SOPs, WIs, and product specifications. You will verify line clearance and readiness of production areas prior to use, monitor, sample, and test materials and finished goods, determine their disposition, and ensure appropriate documentation and labeling.

• Execute rework protocols and support disposition activities as required.
• Initiate and manage LIMS samples and documentation, and identify, document, and communicate non-conforming material in accordance with hold procedures.
• Collect required product, reserve, and customer samples per manufacturing specifications.
• Provide day-to-day coordination and guidance to QA Inspectors during the shift, including assigning and balancing workload as needed.
• Perform inspection, documentation, or system-entry activities during high-volume periods or when coverage is needed.
• Review QA documentation for completeness and accuracy prior to submission to the QA Release team.
• Participate in production and quality meetings, including daily coordination meetings and Gemba walks.
• Provide coaching and instruction to QA Inspectors to support consistent execution of quality procedures and documentation practices.
• Support continuous improvement initiatives and promote a strong quality culture across the manufacturing floor.
• Support QA operational activities including inspection tracking tools, logbooks, sample coordination, production order support, and other quality documentation and administrative tasks required to maintain inspection readiness and compliance.
• Provide support for validation and trial activities across the manufacturing floor.
• Lead training and onboarding efforts for new hires to ensure successful integration, competency development, and adherence to quality and compliance standards.

• 5+ years of quality experience in a regulated environment.
• Proficiency in quality assurance, GMP, FDA regulations, and quality assurance testing.
• Experience with inspection, batch records, CAPA, investigation, and analysis.
• Associate’s degree or equivalent relevant experience.
• Proficiency in Microsoft Office Suite.

• Proven ability to communicate and collaborate with cross-functional stakeholders at all organizational levels, including management.
• Ability to represent the Quality Department with credibility and professionalism during external audits and regulatory interactions.

The role involves performing day-to-day in-process quality checks across manufacturing lines to ensure all finished goods meet product specifications. The position is on the 1st shift, which is busier, requiring interaction with cross-functional managers and directors. Participation in regular production meetings and representation of Quality during internal and external audits is expected. As a hands‑on leader, you will assign tasks, monitor the team for adherence to protocols, provide coaching and guidance, and model behavior for junior Inspectors.

Professionalism and strong communication skills are essential. Work hours are from 7:00am to 3:30pm within a team of six.

The pay range for this position is $65,000.00 – $75,000.00 per year. 5% target bonus annually. Medical, dental, vision, 401(k) match, holiday, vacation, sick leave.

This is a fully onsite position in Orangeburg, NY.

This position is anticipated to close on Mar 16, 2026.

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal‑opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccom for other accommodation options.