QC Associate II - raw materials, inspection in Fremont, CA at Apex Life Sciences

Date Posted: 5/14/2018

Job Snapshot

Job Description


Duties:

  • Performs sampling, testing, inspection of raw materials, conducts lab investigations, problem-solves, and reports aberrant results to management.
  • Includes but not limited to: Packaging components - AQL inspection (e.g., visual defects, dimension testing, and all required attributes.
  • Ships samples to appropriate testing laboratories and prepares paperwork for testing.
  • On call coverage for urgent samples.
  • Ensures sample integrity is intact, paperwork is completed and correct and LIMS entries are performed.
  • Ensures timelines are met.
  • Follows well-defined and established procedures and best practices.
  • Reviews QC test results Documentation: Generates, reviews and/or maintains records or documents in a detailed and consistent manner (e.g., sample summary form, test records, retain sample forms, etc.).
  • Prepares sample reconciliation reports and other reports as needed. Assists with QC's data management, including data review and trending.
  • Performs logbook and/or LIMS entries when using equipment/instruments.
  • Reconciles samples.
  • Perform weekly and monthly reviews of appropriate forms (e.g., test records) and logbooks.
  • Process improvement and compliance: Revises standard operating procedures, training manuals, etc. which are submitted to management for review and final approval.
  • Ensures equipment calibration and preventive maintenance are up-to-date Maintains specific QC files and database records for process and/or quality improvement efforts.
  • Maintain laboratory cleanliness and orderliness.
  • Cross-train in other RM duties such as sampling to cover for other RM members when needed.

Qualifications:

  • 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.
  • 5+ years cGMP or appropriate experience required.
  • Knowledge of ANSI/ASQ Z1.4, DIN ISO 2859 or other sampling standards required.
  • Strong technical writing 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 CA' in the subject line.