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Quality Analyst III

Company: Stefanini, Inc
Location: Irvine
Posted on: November 19, 2021

Job Description:

Stefanini Group is looking for a Quality Analyst in Irvine, CA that can start ASAP.

Exciting opportunity awaits for you! Let us help you get started. Please click the apply button below or call: 248-728-2613/email: Yudishree.Shetty@stefanini.com for faster processing!
Job Description:
Quality Analyst- QC professional at an aseptic, sterile vial fill and finish manufacturing and packaging facility responsible for quality review and approval of protocols, reports, change controls, investigations, CAPAs and other compliance activities (i.e. APRs, stability reports, tech transfers) related to the quality control chemistry laboratories.

The incumbent will be a key team member of the QA team responsible for QA oversight of laboratory compliance, including but not limited to review and approval of investigations, method validations/transfers, change controls, stability management. Under limited guidance, supports and ensures the compliance operations in the laboratory. Partners with the laboratory and other supporting departments for problem resolution.
Executes and interprets key metrics and trend charts using data and/or statistical analysis in support of Annual Product Review and Quality Metrics. Drives quality risk assessment as well as effectiveness checks as part of Change Control and CAPA processes. Demonstrates effective leadership and teamwork to junior and senior level Quality personnel. Complies with all company policies and procedures, including safety rules and regulations, current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements applicable to aseptic/sterile manufacturing and packaging operations. Performs other related duties as assigned.


Requirements:
Bachelor's degree in Chemistry or related field from an accredited college or university and at least 4 years of quality engineering or related QA experience in a cGMP manufacturing environment with at least 10 years in pharmaceutical manufacturing or equivalent.

  • Experience in Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements applicable to aseptic/sterile manufacturing and packaging environment
  • Experience in method validation, method verification, method transfers
  • Strong understanding of compendia compliance
  • Experience of Root Cause Analysis (5 Whys, 6M's, Is/Is Not, FMEA, etc) in support of writing, reviewing, and approving investigations to determine root cause and adequate corrective/preventive actions to prevent recurrence.
  • Experience in Auditing techniques in a cGMP facility.
  • Experience and mastery in technical writing for investigations, protocols, and reports in English language.
  • Knowledge of Lean/5s applicationStrong understanding of GLP
    Ability to transfer compliance knowledge to laboratory team members

Keywords: Stefanini, Inc, Irvine , Quality Analyst III, Professions , Irvine, California

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