• Quality Assurance Manager

    Posting Date 6 months ago(7/10/2018 4:57 PM)
    Requisition ID
    2018-4888
    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 Manager.  The Quality Assurance Manager will manage the Quality Assurance Department and the establishment of compliant and efficient cGxP processes related to operations at Cook MyoSite, Inc.
     

    Responsibilities

    • Primarily responsible for implementing and carrying out short term QA Department/ Function execution plans
    • Oversee daily Quality Assurance and Document Control processes and functions, including providing direct guidance, distributing work tasks amongst specialists /associates /assistants and monitoring completion to ensure the department is operating efficiently
    • Promotes awareness of quality regulatory and compliance requirements
    • QA representative or lead for meetings and projects
    • Responsible for change management activities
    • Provides direction and support for the development and implementation of robust Quality Systems; authors, reviews and approves quality system documents
    • Performs quality reviews, approvals, and dispositioning of batches, as necessary
    • Reviews and approves records and associated data in support of cGMP operation activities

    • Monitors and manages investigation and complaint processes
    • Conducts and documents training events
    • Exemplifies Cook MyoSite’s cultural values and aligns daily actions with department goals and company culture          
    • Demonstrates professional behavior with both internal and external customers that reflects positively on the company and is consistent with the company’s policies and practices
    • Supervise team members and support personnel development to ensure essential job functions and duties are performed at high standards
    • Assist in the recruitment, development, and performance management of staff 

    Qualifications

    • Bachelor's degree or higher, in any life science, biomedical, or related fields, or acceptable related experience, minimum of five years
    • Must possess excellent organizational skills, planning, scheduling, the ability to follow and help drive complex processes, procedures and systems
    • Demonstrate leadership, critical thinking and ability to assist in carrying out departmental goals set by Senior Management
    • Willingness and capability to handle multiple projects and responsibilities

    • High 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:

    • 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 sit at desk, in meetings and/or work on a computer for long or extended periods of time
    • Ability to conduct and hear ordinary conversation and telephone communication
    • Physically capable of standing, walking, stooping, kneeling, crouching, climbing steps and ladders, reaching, twisting and bending on occasion with or without reasonable accommodations
    • Visual and manual acuity for working with computers and equipment

    • Must be able to lift/push/pull up to 25 pounds on an occasional basis with or without reasonable accommodations
    • Must be capable of performing PPE gowning procedures on a frequent 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 a regular basis
    • 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
    • Ability to work under specific time constraints

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