300 Bel Marin Keys Boulevard Novato, CA 94949
Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
The QC Lab Technician is an entry level member of the Quality Control team and is responsible for providing QC support to activities related to document organization and sample and/or laboratory equipment management (e.g. receipt, tracking, testing, disposal). It is expected that he/she will work independently under minimal direction while completing work assignments from routine to semi-routine in nature. Good written and verbal communication skills are essential. Demonstrated ability to work effectively in a quality control testing environment and work with internal customers is preferred for the position.
- Organizes reviewed test records according to departmental policies.
- Organizes documents for archival purposes.
- Receives samples for testing by the QC laboratory.
- Monitors laboratory equipment for calibration needs, maintenance and tracking of issues related to instrumentation.
- Communicates with QC Analysts, Associates, Management and consultants regarding critical equipment issues, events or deviations.
- Provides guidance to internal customers submitting samples for testing.
- Identifies testing requirements based upon predefined testing schemes.
- Manages elements of a Laboratory Information System (LIMS) for sample management and tracking.
- Support continuous improvement in quality systems (procedures and systems) to improve organizational effectiveness, quality assurance compliance, and sample management (cGMP, ICH).
- Work collaboratively with manufacturing/supply chain, quality assurance, regulatory, and project management to ensure timely availability of lot release, stability data, and other required analytical data.
- Relevant experience in a Quality Control function at a technician level is required.
- Experience with analytical systems (LIMS, laboratory control systems, stability/release systems) is required.
- Basic understanding of regulatory agency (FDA) requirement and international guidance (ICH) for drug substance and product under GMP is required as applied to biologics.
- Ability to effectively prioritize and deliver on tight timelines in a fast-paced environment.
- Excellent written and verbal communication skills.
- Experience in analytical data systems (Empower, LIMS) would be a plus.
- Accuracy and attention to detail.
- Excellent cross-functional team participation skills.
- Good problem-solving abilities.
- Ability to be flexible with changing work needs
- Interacts with other functional leaders, project management and QC/AD team personnel
- Interacts with Contract Testing Laboratories, Contract Manufacturing Organizations, consultants and external partners
BS in Molecular Biology, Genetics, Chemistry, Biochemistry, Analytical Chemistry, or a related field (with 0-2 years professional experience).