Lead Quality Assurance Technician

Job Title: Lead Quality Assurance Technician

Job Description

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.

Responsibilities

• 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.

Essential Skills

• 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.

• Associates Degree or equivalent relevant experience.

• Proficiency in Microsoft Office Suite.

Additional Skills & Qualifications

• Proven ability to communicate and collaborate with cross-functional stakeholders at all organizational levels, including senior management.

• Ability to represent the Quality Department with credibility and professionalism during external audits and regulatory interactions.

Job Type & Location

This is a Permanent position based out of Orangeburg, NY.

Pay and Benefits

The pay range for this position is $65000.00 - $75000.00/yr.

5% Target Bonus annually Medical, Dental, Vision, 401k match, etc. Holiday/Vacation/Sick

Workplace Type

This is a fully onsite position in Orangeburg,NY.

Application Deadline

This position is anticipated to close on Mar 3, 2026.

About Actalent

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 [email protected] (%[email protected]) for other accommodation options.