• Quality Assurance Coordinator

    Posting Date 4 months ago(7/12/2018 8:41 AM)
    Requisition ID
    2018-4896
    Job Location(s)
    Pittsburgh PA United States
    Position Type
    Full Time
    Company
    Cook Myosite Inc.
    Category
    Quality
  • Overview

    Cook MyoSite Incorporated, a division of Cook Incorporated, is a growing, forward-thinking biotechnology organization seeking a full time Quality Assurance Coordinator.  The Quality Assurance Coordinator at Cook Myosite Performs detailed quality reviews of batch records and associated records, and ensures quality and compliance with procedural and regulatory requirements.

    Responsibilities

    • Performs quality inspection and documentation for incoming biopsies.
    • Reviews records and associated data in support of cGMP operation activities.
    • Creates batch records, product labels and performs label verification processes.
    • Performs quality reviews of batch records.
    • Participates in company projects as a quality representative.
    • Performs investigation report writing, reviewing and closing for minor level deviations.
    • Clerical functions such as printing, scanning, and filing of QA records and documentation.

    • Performs internal audits and assists with external audits, as needed

    • Ability to be cross-trained in document control activities and perform duties that become necessary to maintain GMP compliance

    • Perform various computer applications on MS Office programs

    • Maintain regular and punctual attendance

    • Must maintain company quality and safety standards

    • Exemplifies Cook MyoSite Core Values

    Qualifications

    • Bachelor’s degree in any life sciences or equivalent and/or relevant experience
    • Must possess excellent organizational skills and the ability follow complex processes, procedures and systems
    • Demonstrate critical thinking and ability to execute goals set by the organization and Department Manager

    • Proficiency in MS Office and other general office equipment
    • Must maintain a high level of professionalism, business acumen
    • Must have effective verbal, written and interpersonal skills
    • Maintain composure and competence under stressful situations; flexibility and adaptability 
    • Ability to work in collaborative and independent work situations and environments with minimal supervision
    • Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing

     

    Physical Requirements:

    • Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time
    • Physically capable of standing, stooping, kneeling, climbing, reaching, twisting and bending with or without reasonable accommodation
    • Climbing a mobile ladder and/or other types of ladders on occasion with or without reasonable accommodation
    • Laboratory and office setting
    • Ability to work under specific time constraints

    • Must be capable of performing PPE gowning procedures on an occasional basis to enter BioSafety Level II including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes required on occasion
    • General office, warehouse and laboratory setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II
    • Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required

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