Quality Assurance Associate

4 weeks ago


Raleigh, North Carolina, United States Actalent Full time

Job Title:
Quality Assurance Associate

Job Description

We are seeking a Quality Assurance Associate to support one of our largest pharmaceutical clients. The QA Associate will be responsible for real-time batch record review on the manufacturing shop floor. Key responsibilities include executing real-time review of batch documentation and other manufacturing documentation for errors, corrections, and compliance.

Additionally, the QA Associate will perform housekeeping and GMP walkthroughs of the facility, initiate or participate in triage for on-the-floor events, work in cross-functional teams to meet and exceed timelines, execute or review room and line clearances, and make quality decisions in real-time according to ICH Q7 and 21CFR211 regulations and internal procedures.

Responsibilities:

  • Execute real-time review of batch documentation and other manufacturing documentation for errors, corrections, and compliance.
  • Perform housekeeping and GMP walkthroughs of the facility.
  • Initiate or participate in triage for on-the-floor events.
  • Work in cross-functional teams to meet and exceed timelines.
  • Execute or review room and line clearances.
  • Make quality decisions in real-time according to ICH Q7 and 21CFR211 regulations and internal procedures.

Requirements:

  • Bachelor's degree.
  • Batch Record Review experience.
  • Shop floor batch record review experience.
  • GMP experience in a manufacturing facility.

Work Environment:

This is a contract position with a duration of 10 Month(s). The person is to be on the shop floor 90-100% of the shift. Not office-based. Dress code is business casual to start with closed-toed shoes, then adherence to gowning procedures is required.

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.

Diversity, Equity & Inclusion:

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. We maintain an inclusive environment through persistent self-reflection, building a culture of care, engagement, and recognition with clear outcomes, and 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.



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