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Job Title: Quality Assurance Specialist

Job Description

The Quality Assurance Specialist plays a crucial role in ensuring the highest standards of product quality and compliance. The majority of the time will be spent on the production floor, collaborating with the operations team to perform verifications, conduct general walkthroughs, and execute onsite reviews and mini audits. This role requires the ability to initiate solutions to problems, such as initiating deviations, and involves reviewing various documents, including executed batch records, cleaning records, and log books. Issuing batch records as needed is also part of the responsibilities. Approximately 80-85% of time will be spent on the production floor, with the remainder in the office. The role requires adherence to specific gowning requirements, from safety shoes to full gowning.

Responsibilities

+ Collaborate with the operations team to perform verifications on the production floor.

+ Conduct general walkthroughs and onsite reviews to ensure compliance.

+ Execute mini audits to ensure processes are correctly followed.

+ Initiate solutions to problems, such as deviations.

+ Review and maintain various documents, including batch records and log books.

+ Issue batch records as needed.

Essential Skills

+ Quality assurance expertise.

+ FDA and GMP compliance knowledge.

+ Experience with batch record review and document control.

+ Audit skills.

+ Pharmaceutical industry knowledge.

Additional Skills & Qualifications

+ Bachelor's degree in any science discipline preferred.

+ 2+ years of experience in a regulated industry (GMP/FDA/ISO).

+ For Sr. roles, 5+ years of regulated industry experience.

+ For Lead roles, 7+ years of regulated industry experience with potential supervisory responsibilities.

Work Environment

The work environment includes shifts of 4am to 4pm for day teams and 4pm to 4am for night teams, operating on a 3 on/2 off/2 on/3 off schedule. Training occurs on the first shift, Monday to Friday from 8am to 4:30pm, lasting 6-8 weeks depending on skills. Specific gowning requirements are in place, ranging from safety shoes to full gowning.

Pay and Benefits

The pay range for this position is $25.00 - $40.00/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 Madison,WI.

Application Deadline

This position is anticipated to close on Jul 25, 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.