Quality SpecialistMust HaveBS in Chemistry or Biology, also open to Material Science, Physics or Chemical Engineering Degree 1-2 years of Quality Control or Quality Assurance Experience 1+ years of experience in Pharmaceutical or related GMP industry Documentation Experience Quality Systems ExperienceJob Description

Quality Specialist Overview: We are seeking a skilled and detail-oriented candidate who can help with equipment validations for pharmaceutical manufacturing. The successful candidate will play a key role in ensuring compliance with industry regulations by executing and overseeing equipment qualification processes, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), Cleaning Commissions, and Cleaning Validations. Additionally, this individual will be responsible for onboarding new equipment into the quality system.

Responsibilities:

1. Conduct IQ, OQ, and PQ activities for manufacturing equipment.

2. Lead and participate in FATs and SATs to ensure equipment meets specified requirements.

3. Oversee and manage cleaning commissions and cleaning validations for equipment in compliance with industry standards.

4. Quality System Onboarding:

• Facilitate the integration of new equipment into the quality management system.

• Collaborate with cross-functional teams to ensure seamless onboarding processes.

• Develop and maintain documentation related to equipment validation and quality system onboarding.

5. Compliance and Documentation:

• Ensure all equipment activities adhere to relevant regulatory guidelines.

• Maintain accurate and up-to-date documentation for validation processes.

• Assist in the preparation for audits and inspections related to equipment validations.

Work Site

This is a fully on-site position in Mount Prospect, Illinois.

Work Environment

Candidate will not be working in the lab. Will begin working in their staging room and then on the manufacturing floor and in the quality group/will have a desk. Manufacturing runs 9 lines, all first shift. 6-8 other people on the Quality team. Company follows FDA and GMP guidelines. 1st shift 8am-5pm

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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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.