Quality Control Stability Technician

Kindeva Drug Delivery is a global pharmaceutical contract developer and manufacturer (CDMO) business headquartered in Woodbury, MN with locations in California, Minnesota, and the United Kingdom.

Kindeva partners with global pharmaceutical companies to commercialize products, with a particular focus on complex drugs and combination products. We are looking for a stability technician to join our team.

Summary of Position
The person hired for the position of Quality Control Stability Technician will support all aspects of the QC stability and material control programs at Kindeva’s manufacturing location in Northridge, CA.  The role entails both physical and administrative duties consisting of product inspection, issuance, reconciliation, and disposal. The stability technician is familiar with stability program requirements defined in quality agreements and department SOPs, and requests and retrieves samples as required per the stability schedule.  In addition to administrative support of the stability program, the technician performs physical inspection of transdermal and aerosol samples for compliance to visual standards throughout the drug product shelf life. This role is responsible for ensuring proper chain of custody with complete and accurate documentation. 

Job Responsibilities

• Ensure the accurate execution of the stability program for all products; which includes ensuring samples are pulled in a timely manner, properly distributing samples, and maintaining compliant storage conditions.
• Request, receive, sort and issue stability and controlled substance samples and associated documentation.
• Review and prepare stability protocols, initiate change control and stability in LIMS and document management system.
• Monitor stability storage conditions, ensure appropriate temperatures and humidity, prepare reports of trends, escalate issues as needed.
• Inspect drug products for compliance to visual standards; escalate non-compliances appropriately.
• Execute timely disposal of retain and stability materials per requirements.
• Fulfill replacement sample requests from QC analysts while maintaining proper documentation for traceability.
• Comply with GMPs and department SOPs.
• Work well in both team and individual environments
• Maintain flexibility to support unexpected sample or inspection requests.

Required Skills & Experience

• Effective time management and multi-tasking abilities
• Effective problem-solving skills
• Demonstrated written and oral communication skills and ability to collaborate cross functionally within a fast-paced manufacturing site.
• Solid understanding of cGMPs as they apply to documentation and Quality Management Systems.
• Microsoft Outlook, Excel and Word experience.
• HS Diploma with 2 years related experience

Preferred

• Pharmaceutical industry experience

• Sample handling experience (pull, log, enter in database, create labels, etc.) is preferred.
• LIMS experience for data entry, retrieval, and sample tracking.