• Quality Control, EM Associate I

    Location US-MD-Columbia
    Job ID
    2018-1252
    # Openings
    1
    Category
    Quality Control
  • Primary Purpose of Position

    Receives and ships in-process and final product samples. Conduct environmental monitoring (EM) according to Standard Operating Procedures (SOPs) in a cleanroom facility.  Use sophisticated laboratory instrumentation and computer systems to collect and record environmental monitoring data.  Performs preventative maintenance of laboratory equipment.  Process and evaluate environmental monitoring samples according to SOPs.  Apply knowledge of Good Documentation Practices (GDP) and Current Good Tissue Practices (cGTP) on a daily basis.  Assist with review and trending of data.

    Principal Responsibilities

    • Receives samples into QC and ships samples for testing to external labs.
    • Performs microbiological monitoring duties including viable air, viable surfaces, and non-viable particulate sampling of clean room facility.
    • Receives, incubates, and reports results from environmental monitoring samples.
    • Performs water and steam sampling of USP water system.
    • Initiates investigations for deviations and out of specification test results.
    • Maintains required QC records and logs.
    • Maintains EM equipment such as cleanings and other preventative maintenance as required.
    • Reviews data associated with environmental monitoring testing and reports anomalies.
    • Assist with the EM lab upkeep and EM data archiving on a daily basis.
    • Reads, understands and follows SOPs to comply with all applicable regulations
    • Interacts effectively with company management and internal departments.

    Other duties, as assigned

    Qualifications

    • Quality focused and results oriented
    • Competent with strong problem solving abilities
    • Ability to interact professionally with multiple departments
    • Excellent organizational, written and verbal communication skills
    • Ability to manage multiple and varied tasks, and prioritize workload
    • Ability to work professionally
    • Experience with Microsoft based applications, and ability to learn internal computer systems
    • Good documentation skills
    • Flexibility and ability to adjust to changing priorities and unforeseen events; excellent time management skills
    • Ability to work consistently in a fast-paced environment with little supervision
    • Good interpersonal skills and the ability to work effectively and efficiently in a team environment.
    • Minimum 1 year work experience within the biotechnology or pharmaceutical industry
    • Proficiency in other compliance disciplines, i.e., cGTP, GLPs, GDP, GxPs
    • BS degree or 3 years relevant work experience required
    • BS in scientific discipline preferred

    Ability to work flexible hours, including possible off-shifts and weekends.

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