Location: Raleigh,NC, USA
Job Title: Quality Assurance AssociateJob 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 as well as other essential responsibilities.
Responsibilities
+ Execute real-time review of batch documentation and other manufacturing documentation, analyzing for errors, corrections, and compliance.
+ Perform housekeeping and GMP walkthroughs of the facility.
+ Initiate and 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 regulations ICH Q7 and 21CFR211 and internal procedures.
Essential Skills
+ Experience in batch record review.
+ GMP experience in a manufacturing facility.
+ Bachelor's degree.
+ Quality assurance knowledge.
Additional Skills & Qualifications
+ Experience with SAP.
+ Familiarity with Veeva Vault.
+ Proficiency in Trackwise.
+ Knowledge of biologics manufacturing.
+ Experience in vaccine manufacturing.
Work Environment
The work shift is from 7am to 7pm, Sunday to Wednesday (Shift A). The team includes day and night shifts, with rotations that always include working on a Saturday or Sunday. Employees work 3 days one week and 4 days the following week. The role requires being on the shop floor 90-100% of the shift, and it is not office-based. The dress code is business casual to start, with closed-toed shoes, followed by adherence to gowning procedures.
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 ...@actalentservices.com ( ...@actalentservices.com) for other accommodation options.