Marin Metro Area, CA
- 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 of 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).