• Sr. Quality Analyst - Sterility Assurance

    Job Locations US-GA-Union City
    Job ID
    2018-1344
    Category
    Quality Control
  • Overview

    The  Sr. Quality Analyst, Sterility Assurance is responsible for QC microbiological aspects of cGMP compliance and testing ensuring microbiological quality of products, manufacturing process areas, and facility/utilities. .

    Responsibilities

     

    Responsibilities:

    • Responsible for QC microbiological aspects of cGMP compliance and testing.
    • Assist in the identification of microbiological root cause analysis and provide technical advice required.
    • Participate in the investigation and review of alert/action limit investigations and implement corrective action as appropriate.
    • Participate in validation activities involving microbiology as needed.
    • Participate in the investigation of microbiological product OOS results as required.
    • Technical writing assignments such as SOPs, protocols, final reports, trend reports, risk assessments, laboratory investigations, etc.
    • Assist in the review of EM and product release data.
    • Microbiology representation and participation in cross functional site meetings.
    • Initiates and completes CAPAs and Change Controls in accordance with site procedures.
    • Proactively identifies and implements lab process improvements, lean initiatives.
    • May be required to observe manufacturing operations on the floor to provide constructive feedback for strengthening microbial controls and aseptic practices.
    • Support roll out of relevant training and/or provide coaching to personnel related to Microbiology and Microbiological controls
    • Ensure all work performed is in compliance with required regulatory standards, conforms to company policies and SOPs.
    • Participate in inspections for regulatory/internal/corporate audits.
    • Support other duties assigned by QA Microbiology management as required
    • Ensure compliance with safety, health, environmental and cGMP and other applicable regulations.
    • Support Microbiology projects as needed.
    • Prepare and analyze trend analysis reports microbiology test data (EM, PM, water, etc.).
    • Support LIMS system for data entry and approval.
    • Review and approve laboratory documentation.

     

    Qualifications

     

    • Bachelors/Masters in Microbiology preferred. 5+ years of relevant experience preferably in a QC Microbiology Laboratory within the pharmaceutical or biotechnology industries.
    • Knowledge of sterile products manufacturing processes and testing preferable. Knowledge of aseptic manufacturing processes is ideal.
    • Excellent communication skills, both verbal & written.
    • Adaptable and flexible.
    • Collaboration and team work.
    • Results and performance driven.
    • Good time management and attention to detail.
    • Maintains the highest standards of ethical behavior.
    • Experience with electronic systems such as LIMS, CATSWeb etc., is ideal.

     

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