Quality Control Associate – Sample Coordinator
Integrity Bio, Inc. specializes in biologics formulation development and drug product manufacturing. We have formulated over 200 biologics including vaccines, antibodies, proteins, and peptides for more than 150 firms. Integrity Bio specializes in hard-to-formulate products in liquid and lyophilized forms.
We are located in Camarillo and Thousand Oaks California, the center of a highly concentrated cluster of 10,000 biotech professionals. Demand for our research services increased by 30% in the past year, driving continued expansion and need for great people.
We are seeking candidates for the position of Quality Control Associate – Sample Coordinator.
- Oversee and independently perform a variety of sample management duties (receiving, handling, labeling, inventory, transport, check-out, return, disposal, etc.) for various samples to include raw materials, in-process, lot release, stability, and reference standards.
- Manage incoming and outgoing QC samples, ensuring timely, effective, and compliant operation in support of manufacturing and laboratory operations.
- Communicate sample status to laboratory and other operational groups.
- Respond to environmental chamber alarms and participates in on-call responsibilities.
- Maintain storage chambers in support of the laboratory and QC materials.
- Perform work assignments accurately and in a timely and safe manner.
- Coordinate sample shipments and activities associated with contract testing laboratories.
- Support activities associated with Change Control, Nonconformance Investigations, CAPAs, Work Orders and Planned Deviations.
- Preserve department records and documentation for stability programs and shipment requests.
- Operates within a team-based environment and participates in team activities.
- High attention to detail in all work activities.
- Strong interpersonal, written, and oral communication skills.
- Excellent organizational and multi-tasking skills.
- Must be able to prioritize workload and meet challenging deadlines.
- Solid customer service skills to include attention to detail, accuracy, and confidentiality.
- Inventory / LIMS software experience preferred.
- Works overtime when required.
- Good understanding of relevant regulatory/industry standards and requirements.
- Familiarity with Microsoft Office.
- Ability to work in a collaborative team environment.
- Able to work safely in a laboratory environment and wear required protective equipment.
- Frequent mobility required. May require standing, up to 4-6 hours in a work shift.
Education: Associates degree or Bachelor’s degree in biology, chemistry, or related life sciences
1-2 years’ experience in a cGMP laboratory, preferably related to pharmaceutical industry sample operations