"Alerted.org

Quality Assurance Specialist

1st and 3rd shift

Job Description

The QA Specialist will primarily be active on the production floor, supporting the operations team with verifications, conducting walkthroughs, and performing onsite reviews and mini audits to ensure compliance with operational standards. This role involves identifying and resolving issues, such as initiating deviations, and includes responsibilities like reviewing documents, executed batch records, cleaning records, and logbooks, as well as issuing batch records when necessary. The position demands 80-85% of time spent on the floor, with the remainder in the office. The role also requires adherence to specific gowning requirements, ranging from safety shoes to full gowning.

Responsibilities

+ Support the operations team by performing verifications and walkthroughs on the production floor.

+ Conduct onsite reviews and mini audits to ensure compliance with established standards.

+ Initiate deviations and propose solutions to identified problems.

+ Review and manage documents, including executed batch records, cleaning records, and logbooks.

+ Issue batch records as needed.

+ Comply with specific gowning requirements in designated areas.

Essential Skills

+ Experience in quality assurance within a regulated industry.

+ Familiarity with GMP, FDA, and ISO standards.

+ Proficiency in batch record review, document control, and CAPA.

+ Ability to conduct audits within the pharmaceutical sector.

Additional Skills & Qualifications

+ Bachelor's degree in any science discipline preferred.

+ For Specialist: Minimum of 2+ years of experience in a regulated industry.

+ For Sr.: Minimum of 5+ years of experience in a regulated industry.

+ For Lead: Minimum of 7+ years of experience in a regulated industry, with potential to supervise or lead.

Pay and Benefits

The pay range for this position is $62000.00 - $90000.00/yr.

Medical, dental, 401K, vision

Workplace Type

This is a fully onsite position in Waunakee,WI.

Application Deadline

This position is anticipated to close on Sep 19, 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.