• Quality Assurance Associate

    Location US-NJ-Bridgewater
    Posted Date 2 weeks ago(12/31/2018 2:37 PM)
    Kashiv Pharma LLC
  • Overview

    Kashiv Pharma, LLC. is an emerging pharmaceutical research and drug delivery company focused on developing innovative technologies, improved medicines and life cycle management products. Kashiv also offers contract research and development services to pharmaceutical clients in need of formulation and analytical development expertise and/or clinical supply manufacture.


    Position Summary


    The Quality Assurance Associate is responsible for proving QA support to ensure operations are conducted in accordance with current Good Manufacturing Practices.


    Key responsibilities of the position include, but are not limited to:


    • Provide QA support during manufacturing and analytical operations.
    • Coordinate submission of samples for QC analysis.
    • Assist all departments in the generation of quality system documentation; such as SOPs, deviation/investigation reports, equipment/system qualification protocols and reports, and change controls.
    • Review and approval of manufacturing and packaging master and executed batch records.
    • Quality release of raw materials and finished products.
    • Assist in quality investigations (including OOS investigations); work with impacted functions in the development of required CAPA items.
    • Interface with customers to resolve quality issues.
    • Performs other functions as required or assigned
    • Complies with all company policies and standards


    Position Requirements and Qualifications

    • Bachelors Degree in Science (required); Preferably in Pharmaceutical Sciences or Technology, Chemical Engineering, etc.
    • Minimum of 3 to 6 years relevant experience in a pharmaceutical quality assurance/control environment.
    • Direct experience in manufacturing QA support (sampling, room/line clearance, cleaning verification)
    • Experience in GMP document review (batch records, SOPs).
    • Understand the requirements and procedures related to document control and Quality Assurance.
    • Ability to work with teams - good interpersonal skills.
    • Excellent communication skills: verbal and written.
    • Organization and time management skills, detail oriented.
    • Good computer skills, including in depth knowledge of Word, Excel and spread sheet software required.
    • Knowledgeable in GMP aspects of the Pharma industry.

    Work Environment & Physical Demands


    General work environment and physical demands as required to successfully perform the essential functions of this job. Ability to work flexible hours as needed. Ability to work under pressure and meet deadlines. Some travel may be involved.


    Supervisory Responsibility, if any:       No


    This position description is not a complete list of all responsibilities, duties or skill required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.



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