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Job Title: Quality Specialist

Job Description

The Quality Specialist is responsible for executing quality system activities to ensure compliance with ISO standards, cGMPs, and customer expectations. This role includes tasks such as documentation, audits, training, and support for manufacturing and testing processes.

Responsibilities

+ Monitor and utilize quality management systems and software.

+ Review batch records and manufacturing procedures.

+ Support and train staff on quality policies and procedures.

+ Assist with audits, SOPs, and change control documentation.

+ Maintain records and manage equipment calibration schedules.

+ Enforce compliance and safety standards.

+ Support investigations and release of materials.

Essential Skills

+ Quality assurance and quality control expertise.

+ Audit processes and document control.

+ Compliance with ISO standards.

+ Strong communication and teamwork abilities.

+ Decision-making and problem-solving skills.

+ Performance-driven and organizational awareness.

Additional Skills & Qualifications

+ QS I: High school diploma with minimal experience.

+ QS II: High school diploma with 1–3 years of experience.

+ QS III: Bachelor’s degree in science with over 3 years in an ISO/FDA environment.

Work Environment

This position involves training from 8 AM to 4:30 PM, Monday through Friday for 2-3 weeks. The regular shift is from 3:00 PM to 11:30 PM, Monday through Friday. The work environment is in a manufacturing setting where standing or walking during the shift is required. There is exposure to chemicals, pathogens (BSL2), and moderate noise levels. Occasionally, work near mechanical parts and in cold conditions is necessary. This role offers opportunities for growth, great benefits including health, vision, and dental, and the chance to impact other departments with the potential for overtime if needed.

Job Type & Location

This is a Contract to Hire position based out of Lexington, Kentucky.

Pay and Benefits

The pay range for this position is $23.00 - $26.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Lexington,KY.

Application Deadline

This position is anticipated to close on Sep 11, 2025.

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.