Job Title: Quality Assurance SpecialistJob Description

We are seeking a dedicated Quality Assurance Specialist to join our team. The ideal candidate will receive product quality complaints, document investigations, and triage safety events. You will ensure compliance with regulatory requirements, maintain high-quality standards, and perform data analysis in support of product quality complaint investigations.

Responsibilities

• Receive product quality complaints.

• Document investigations in the quality system.

• Triage safety events to the relevant department.

• Support product quality complaint investigations.

• Ensure compliance with applicable regulatory requirements.

• Maintain programs and processes to ensure high-quality products and compliance with GMPs and GLPs.

• Perform data analysis in support of product quality complaint investigations and quarterly trend analysis.

• Assist lead/coordinator with investigations and CAPA related to manufactured products.

• Manage product complaint samples from receipt through destruction.

• Receive general instructions on routine work and detailed instructions on new assignments.

Essential Skills

• Experience with deviations, investigations, and CAPA.

• 1-2 years of pharmaceutical experience.

• Critical thinking skills.

• Ability to work with cross-functional teams and CMOs.

• Quality assurance experience.

Additional Skills & Qualifications

• B.S. in science preferred.

• Veeva experience is a plus.

• Manufacturing and packaging background .

• Aptitude and ability to learn and train.

• Preferred experience with OSD or biologics.

Work Environment

This position follows a hybrid work schedule with onsite work required on Tuesday, Wednesday, and Thursday, and work-from-home options available on Monday and Friday.

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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.