QC Associate III - documentation, improvements in Fremont, CA at Apex Life Sciences

Date Posted: 3/14/2018

Job Snapshot

Job Description


  • Create/updates raw material (RM) specifications and SOPs as required.
  • Maintains RM released data lot packets and reports.
  • Create RM final reports.
  • Works with SQM and Quality Compliance on material qualification.
  • Coordinates with SCM and Logistics the schedule for creation of new raw material specifications.
  • Review raw material lot packets to ensure appropriate samples are taken and tested according to specification.
  • Performs final disposition and release of raw materials in SAP.
  • Monitors material testing and release status and turnaround times.
  • Performs an Owner role for Change Controls and Deviations.


  • Independently writes and updates raw material specifications and reports.
  • Responsible for ensuring all raw material documentation and reports are reviewed and are in accordance with the raw material specifications.
  • Generates, reviews and/or maintains records or documents in a detailed and consistent manner.
  • Prepares sample reconciliation reports, periodic trend reports, generate metrics and other reports as needed.
  • Reviews and reconciles reports with internally produced data.
  • Maintains raw material released data lot packets and reports, creates raw material final reports.
  • Process improvement and compliance: Pro-actively reviews and develops new raw material specifications, standard operating procedures, protocols etc.
  • Enters data in databases as appropriate.
  • Performs an Owner role for Change Controls and Deviations.
  • Train in other RM duties such as sampling and inspection (including packaging components) to cover for other RM members when needed.


  • Bachelors degree in a Scientific Discipline required
  • In depth experience in a laboratory environment with direct experience in bio-analytical techniques and equipment related to the testing of biotechnological products or chemicals Six (6) years cGMP or appropriate experience required.
  • Knowledge of CFR, USP, and ICH required.
  • Knowledge of SAP, Trackwise and LIMS desired.
  • Working knowledge of Microsoft Office systems, LIMS, lab instrumentation and other relevant systems
  • Highly productive, attention to detail, ability to manage time and prioritize tasks with input from manager to meet time lines.
  • Demonstrated problem-detection and problem-resolution skills required.

***For immediate consideration, please email your updated resume to awoods@apexlifesciences.com with 'QC Associate III CA' in the subject line.