QA Analyst I (Pharmaceutical)

  Apply  

Irfa******

  • United States 
  • Last Update: 11.01.2019 at 12:00

Job Type
Full Time
Start
ASAP
Duration
6 Month +
Place
South San Francisco, California, United States
Country
United States

Category


Quality Assurance and Business Operations

Description


Duties

  • Collect data from multiple QC labs and coordinate any corrections.
  • Scan Lot Release, Reference Material, Cell Bank into validated system.
  • Manage the archival of lot release, tox lots, and CMO data
  • Maintain database for all documents received.
  • Coordinate the preparation and retrieval of data to and from offsite storage location.
  • Receive, manage, and distribute Clinical Sampling Plans, Protocols, Memos, CMO CoAs, Testing Request Forms.
  • Manage and drive to completion requests from different QC groups.
  • Compile analytical data for bulk, final product.
  • Adhere to cGMP compliance guidelines.
  • Support internal and external audits (as needed).
  • Accomplish corporate, operational and departmental goals
  • Apply expertise of compliance requirements to maintain an inspection-ready state.
  • Train personnel on relevant business processes.
  • Provide data and documents to support product quality impacting investigations
  • Collect data from multiple QC labs and coordinate any corrections.
  • Scan Lot Release, Reference Material, Cell Bank into validated system.
  • Manage the archival of lot release, tox lots, and CMO data
  • Maintain database for all documents received.
  • Coordinate the preparation and retrieval of data to and from offsite storage location.
  • Receive, manage, and distribute Clinical Sampling Plans, Protocols, Memos, CMO CoAs, Testing Request Forms.
  • Manage and drive to completion requests from different QC groups.
  • Compile analytical data for bulk, final product.
  • Adhere to cGMP compliance guidelines.
  • Support internal and external audits (as needed).
  • Accomplish corporate, operational and departmental goals
  • Apply expertise of compliance requirements to maintain an inspection-ready state.
  • Train personnel on relevant business processes.
  • Provide data and documents to support product quality impacting investigations

Skills

  • Sound knowledge of cGMP or equivalent regulations
  • Ability to interpret Quality standards for implementation
  • Ability to make sound decisions about scheduling, allocation of resources, and managing priorities
  • Ability to communicate clearly and professionally both in writing and verbally Flexibility in problem solving and work hours to meet business objectives
  • GMP experience preferred with particular emphasis on Quality Control
  • Experience working with Labware LIMS, SAP and Trackwise are preferred

Get In Touch


downloadfilmterbaru.xyz bigoporn.club bok3p.site sablonpontianak.com