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Job Title: Quality Assurance Specialist

Job Description

The Quality Assurance Specialist will primarily work on the production floor assisting the operations team with verifications, conducting general walkthroughs of the area, and performing onsite reviews and mini audits to ensure compliance. This role involves problem-solving tasks, such as initiating deviations, and reviewing various documents including executed batch records, cleaning records, and log books. Approximately 80-85% of the work will be conducted on the floor, with the remainder in the office. There are specific gowning requirements in certain areas ranging from wearing safety shoes to full gowning.

Responsibilities

+ Assist operations team with verifications and general area walkthroughs.

+ Perform onsite reviews and mini audits to ensure compliance.

+ Initiate deviations and contribute to problem-solving solutions.

+ Review and issue batch records, cleaning records, and log books.

+ Spend majority of time on production floor, with some office work.

Essential Skills

+ Quality assurance expertise.

+ Familiarity with FDA regulations.

+ Experience in batch record review.

+ Knowledge of CAPA and audit processes.

+ Proficiency in document control.

+ Experience in pharmaceutical industry.

Additional Skills & Qualifications

+ Bachelor's degree in any science discipline preferred.

+ 2+ years of experience in regulated industry (GMP/FDA/ISO) for Specialist role.

+ 5+ years of experience in regulated industry for Sr. role.

+ 7+ years of experience in regulated industry for Lead role.

+ Experience supervising or leading teams is advantageous.

Work Environment

The work environment includes shifts with 8 employees divided into 2 teams for day and night schedules. Day shifts are from 4am to 4pm, and night shifts are from 4pm to 4am, following a 3 on/2 off/2 on/3 off rotation. Training occurs on 1st shift (Monday-Friday, 8am-4:30pm) for 6-8 weeks depending on skills. The majority of work is done on the production floor, with some office work involving interaction with the EQMS system. Dress code varies from safety shoes to full gowning depending on the area.

Pay and Benefits

The pay range for this position is $29.81 - $40.86/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 Madison,WI.

Application Deadline

This position is anticipated to close on Aug 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.