• Specialist I, Quality Assurance

    Posted: 07/17/2022


    The Quality Assurance Manufacturing Specialist I is an experienced quality professional responsible for QA oversight of manufacturing/production processes and Quality Control laboratories. 

     The Specialist position operates with considerable latitude, and is responsible for system level oversight and complex root cause analysis Quality System work.  The specialist also serves as a subject matter expert in Emergent quality systems and directly interacts with regulators during on-site inspections. This position Frequently interacts with department managers, internal customers, and other cross functional peers to gain alignment and make quality related decisions.

    Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

    •    Provide quality on the floor support and oversight to help resolve manufacturing issues of moderate to high complexity without oversight
    •    Performs audits of the manufacturing facilities and laboratories to ensure compliance with internal Emergent procedures and cGMPs 
    •    Reviews Product Manufacturing and Testing records to ensure product specification and process requirements are consistently met in accordance with Emergent standard operating procedures
    •    Ensure documentation supporting product manufacturing and testing follows good documentation practices (GDP) and principles of data integrity
    •    Define, prepare and communicate performance metrics and trend analyses to senior management 
    •    Supports Major and Critical Non-conformance investigations inclusive of a detailed root cause analysis and corrective actions
    •    Serves as a decision-maker on significant procedure and site projects
    •    Coordinate/lead cross functional teams in process mapping and other exercises designed to facilitate process and system understanding
    •    Serve as Quality representative over an integrated process team and represent Quality Assurance as part of the Value Stream Management Committee 
    •    Coordinate the completion of product release deliverables and ensure product release goals are met by Quality Assurance
    •    Implements continuous improvements projects in support of Quality Assurance and Manufacturing/QC
    •    May serve as system owner for one or more quality systems or be the lead of an integrated process team
    •    Directly supports internal and external inspections and audits by directly interacting with auditors as a subject matter expert for quality systems
    •    Responds to customer inquiries and complaints. Investigates customer complaints for root cause and takes appropriate action as required

    The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions. 


    •    BA/BS (preferably in an applied science)
    •    >8 years of experience working in an FDA regulated industry with at least 5 years of experience within Quality Assurance 
    •    Experience with aseptic processes, clean room gowning, and Pharmaceutical quality system work preferred
    •    Candidate must exhibit strong interpersonal and communication skills, strong oral and written communication skills
    •    Familiarity with performing Root Cause Analysis, CAPA, and Change Control. 
    •    Ability to make sound decisions regarding high complexity compliance-related issues with low supervision.
    •    High level of personal/departmental accountability and responsibility.
    •    Strong Understanding of pharmaceutical industry guidance (ICH, CFR 21.210-211, USP) and current industry trends. 

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Asian Pacific American Chamber of Commerce (APACC)

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