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Quality Control Senior Associate

Thousand Oaks, CA

Project management skills:
  • On time delivery of global projects, timely communication of status (on-track/off-track), solutions driven.

Analytical Method Validation/Transfer Experience:
  • Experience drafting analytical method validation/transfer protocols and reports
  • Microsoft Word and use of document management software (ie, EDM Quality)

Biotechnology Working Lab Experience:
  • Experience working in the lab which will serve them well in supporting analytical method validation/transfer documentation

Day to Day Responsibilities:
First 30 Days:
  • Completion of training on Amgen systems and on their job function.

Day to Day:
  • Project managing method support activities for the QC labs such as transfers, validations, method performance evaluation metrics, reports, and workshops.
  • Managing the redaction of documents in support of regulatory filings or commitments.

Summary:
  • Under general supervision, this position will support our Quality Control organization as a project manager with primary focus on analytical method transfer and analytical method validations.
  • In addition this role will work closely with the HPLC, Bioassay, Compendial, Immunology, Microbiology, and Raw Materials groups in the successful and on time delivery of transfers and validations.
  • Including managing project schedules, facilitating status update meetings, driving issue resolution, communicating and presenting to leadership, managing global conferences, reviewing and assimilating data, and coordinating performance monitoring activities.

Project management skills:
  • On time delivery of global projects, timely communication of status (on-track/off-track), solutions driven.

Analytical Method Validation/Transfer Experience:
  • Experience drafting analytical method validation/transfer protocols and reports.
  • Microsoft Word and use of document management software (ie, EDM Quality).

Biotechnology Lab Experience:
  • Experience in the lab which will serve them well in supporting analytical method validation/transfer documentation.
Technical Writing:
  • If not specific method validation/transfer document experience, more general technical writing experience of SOPs, Methods, Protocols, Reports.
             "This posting is for Contingent Worker, not an FTE"

 
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