• Quality Control, EM Associate II

    Location US-MD-Columbia
    Job ID
    2018-1253
    # Openings
    1
    Category
    Quality Control
  • Primary Purpose of Position

    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.  Process and evaluate environmental monitoring samples according to SOPs.  Review and trend data for documentation of procedures and reports.  Initiates and writes investigations and SOPs.  Receives and ships in process and final product samples.  Apply knowledge of Good Documentation Practices (GDP) and Current Good Tissue Practices (cGTP) on a daily basis

    Principal Responsibilities

    • 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 and performs investigations for deviations and out of specification test results.
    • Maintains required QC records and logs.
    • Reviews EM data and documents and reports anomalies.
    • Tracks and trends environmental monitoring data.
    • Receives samples into QC and ships samples for testing to external labs.
    • Writes and revises supporting SOPs and processes related to environmental monitoring.
    • Reads, understands and follows SOPs to comply with all applicable regulations
    • Provides quality/technical expertise and oversight for environmental monitoring.
    • Assist with the purchasing of EM supplies and equipment.
    • Performs gown certifications.
    • Provides training for new employees on environmental monitoring.
    • Maintains EM equipment such as cleanings and other preventative maintenance as required.
    • Assists with EM lab upkeep and EM data archiving on a daily basis.
    • 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
    • Ability to work flexible hours, including possible off-shifts and weekends
    • BS in scientific discipline required
    • Minimum 2 years work experience within the biotechnology or pharmaceutical industry performing EM or microbiology duties
    • Proficiency in other compliance disciplines, i.e., cGTP, GLPs, GDP, GxPs
    • Must be able to lift 40 pounds repeatedly

    Osiris Therapeutics, Inc. is an Equal Opportunity Employer with a commitment to diversity. Applicants are considered on the basis of individual merit without regard to race, color, national or ethnic origin, gender, gender identity, sexual orientation, marital status, veteran status, pregnancy, age, religion, disability, genetic information, or any other characteristic protected by law.

     

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