Quality Control Associate - San Diego, United States - Arcturus Therapeutics Inc

Arcturus Therapeutics Inc

Verified Company

San Diego, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

WHY WORK FOR ARCTURUS?

THE OPPORTUNITY
Arcturus Therapeutics seeks a highly motivated, hands-on individual to join our expanding Analytical Development/Quality Control team as a Quality Control Stability Associate

Temp.

In this role, the Stability Coordinator will interact with cross-functional teams and the CMO/CTL to establish and implement real-time stability studies, including, but not limited to, notification for stability sample pulling, planning for shipment at a third-party lab, and reviewing and summarizing the test results generated after each time point.

WHAT YOU WILL CONTRIBUTE

The individual will also be responsible for collaborating with stability studies to ensure the timely execution of timepoint testing per the requirements stated in each stability protocol.
Participate in the planning and review of realtime stability design and/or protocol.
Coordinate with CMO/CTL to finalize logistics for product stability study setup and initiation.
Organize shipment of samples for Arcturus managed third party lab for testing as described in the protocol.
Own and participate in meetings related to stability initiation and transfer.
Request, receive, and track the raw data, and report for completed time points.
Review and organize product stability data and study reports.
Notify quality management for outofspecification or outoftrends discovered during the review of stability results.
Formatting and reviewing stability summary tables for accuracy and compliance with current cGMP and Arcturus SOP.
Write/revise stability protocol, prepare technical reports and presentations that summarize stability study trends/results, and provide data interpretation.
Enter stability data into electronic databases/SLIM software accurately and efficiently.
Assist in analyzing stability data trends over time. Collaborate with team members to identify patterns, deviations, or anomalies requiring further investigation.
Support in activities such as creating draft reports and summaries.
Ensure the integrity and accuracy of stability data by adhering to established data entry procedures and quality standards. Verify data entries for completeness and correctness.
Analyze, review, and interpret chemical and bioanalytical datasets.
Perform other duties as assigned.

WHAT WE SEEK

BS or MS in cellular and molecular biology, immunology, biochemistry, chemistry, or other relevant biological disciplines.
23 years of industry experience is preferred.
Knowledge and understanding of ICH and WHO guidelines for stability testing.
Solid understanding of cGMP (21 CFR 210, 211, etc.) and data integrity requirements appropriate to quality control.
Expertise in reviewing data from multiple analytical techniques, such as CE, HPLC, LC-MS instrumentation, UV-Vis, Karl Fischer, fluorescent plate readers, osmometers, and viscometers.
Experience with LNP or mRNA delivery systems and analytical techniques is a plus.
Experience in data analysis with Excel, JMP statistical software, and working with LIMS software is a plus. Strong attention to detail and a high level of accuracy in data entry tasks.
Familiarity with the requirement of phaseappropriate qualification and validation of analytical procedures.
Ability to think critically and creatively, pay close attention to details, and work independently; ability to determine appropriate resources for ongoing stability studies.
Comfortable working in a highly innovative environment and having a strong ability to cope with change.
Selfstarter with the ability to take the initiative and drive processes.
Excellent written and verbal communication skills, and proven ability to manage multiple experiments.
Excellent organizational skills, attention to details, and proven ability to work under mínimal supervision within a multidisciplinary environment.

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EDUCATION