QC Technician

Novato, CA 94949

Posted: 07/19/2019 Employment Type: Contract Industry: Quality Job Number: 6566

Job Description


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.

 

Description:       

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.

 

Duties:
  • 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.   

 

Job Requirements

Skills:            

  • 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

Education:          

BS in Molecular Biology, Genetics, Chemistry, Biochemistry, Analytical Chemistry, or a related field (with 0-2 years professional experience).

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