Job Title: Quality Control Scientist I

Interested candidates can send updated resumes to browoodruff @actalentservices. com

Job Description

Join our dynamic Quality Department to support the testing and analysis of cGMP produced viral vectors and cells. Collaborate closely with the QC manager and high-level QC staff to cultivate and enact strategic direction within the GMP area. With guidance from high-level staff, engage in QC method performance and development, microbiological environmental monitoring sample analysis, SOP writing and revision, equipment maintenance and monitoring, and materials management for QC and Production supplies. Laboratory testing will encompass PCR, qPCR, ddPCR, Gel Electrophoresis, and pH measurement. Operate within the Quality Management System applicable to the manufacture of phase-appropriate material in the CMF.

Responsibilities

• Ensure all product samples are adequately labeled and document all aspects of sample allocation and transition in the respective format and systems.
• Take full accountability for product allocation across sample requirements and storage conditions.
• Evaluate processes associated with sample management to identify gaps and implement improvements.
• Complete, review, file, and archive documentation according to Standard Operating Procedures (SOPs).
• Maintain compliance with applicable regulatory requirements for cellular and gene therapy products.
• Perform tasks in accordance with established policies, procedures, and techniques, requiring training and working knowledge related to tasks performed.
• Work under close supervision of experienced staff and leadership.
• Function effectively in a diverse and collaborative team environment, utilizing clear communication to deliver high productivity.
• Document all activities performed according to established guidelines.

Essential Skills

• BS degree in Biology or another science field.
• 6 months or more of Industry Quality Experience.
• Understanding of regulatory and documentation constraints in a GMP environment.

Additional Skills & Qualifications

• Prior GMP experience, report writing, and documentation review are preferred.
• Experience from GMP manufacturing is highly preferred.

Work Environment

The work environment is highly collaborative, with a team-oriented approach where members work closely with one another. The team size ranges from 10-12 individuals per shift, with a business casual dress code. The position is located at the Dublin ADC, operating on a flexible first shift schedule from Monday to Friday, 8:00 AM to 4:30 PM.