Analyst II, Sample Control

oxfordbiom•Durham, NC

About The Position

At OXB, our people are at the heart of everything we do. We’re on a mission to enable life-changing therapies to reach patients around the world—and we’re looking for passionate individuals who embody our core values every day: Responsible, Responsive, Resilient, and Respectful. Following the expansion of our US footprint with the acquisition of a new commercial-scale viral vector facility in Durham, North Carolina we have some new opportunities to join us. We’re currently recruiting for a Analyst II, Quality Control to join our Microbiology team. In this role, you will be establishing a new GMP Sample Services function for our Durham manufacturing facility, playing a key part in advancing our mission and making a real difference.

Requirements

BA, BS or MS in Biology, Biochemistry, Pharmaceutical Science or related disciplines
1-3 years of experience in a cGMP environment is preferred
Experienced in writing and reviewing technical documents.
Superb organizational, analytical and communications skills
Self-directed individual who is able to work with limited direction in a fast-paced, goal-oriented environment.

Responsibilities

Manage the day to day operations of incoming and outgoing QC samples, ensuring a timely, effective, and compliant operation in support of manufacturing operations.
Establish and maintain a good working relationship with cross-functional representatives for receiving and processing samples submitted to QC.
Responsible for ensuring appropriate documentation is in place prior to sending samples to contract testing laboratories.
Responsible for pulling stability samples at designated time points as per the stability protocol and stability pull schedule.
Responsible for sample inventory management within QC, including sample aliquoting and discard, as appropriate.
Responsible for ensuring that sample management forms/documents adhere to GMP requirements.