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    Quality Assurance Specialist - Worcester, United States - Spectraforce Technologies

    Spectraforce Technologies
    Spectraforce Technologies Worcester, United States

    4 weeks ago

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    Description

    Position Title:
    Quality Assurance Specialist III

    Length of Contract: 12 months


    Location/Site:
    Worcester, MA


    Hybrid Onsite Schedule:
    Hybrid


    Job Description:
    Regulatory Compliance & Quality Systems Specialist / Sr.

    Specialist - looking for 2-3 staff in this area, also with 10+ years of experience supporting operations regulatory inspections, audits, and working within the Quality Systems of Change Control, Nonconformances and Corrective and Preventive Actions (CAPA), quality risk management.

    We could take on 1 person with less experience but need at least 5+ years to be sure they can deliver at the level needed with minimal initial training / skill building.

    They should be familiar with the systems we utilize such as Trackwise, Veeva.

    What are the top 3-5 skills and education required for this position:

    Education:
    Bachelor's degree in Science or Engineering


    Top 3-5 skills: familiar with US FDA CFRs, regulatory guidance, and cGMPs; prior experience in an audit, compliance or investigation/CAPA role; experience with the following quality systems: risk management, change management; prior experience in a quality assurance role in a biologics manufacturing operation, or similar; could also have prior role in training/learning & performance within Quality; problem-solving techniques for root cause analysis in investigations.


    Responsible for assisting with the internal audit system that will assure that all production and support functions at the manufacturing facility operate in compliance with all applicable regulations and standards.

    Ensures the organization's compliance with FDA, ISO, AATB, and all other applicable international and state regulatory requirements, best industry practices, the harmonized corporate and internal processes.

    Compile Quality metrics for QSMR, Tier board etc. and identify and bring issues to management when a compliance gap or quality issue is identified.


    Responsibilities:
    Assists with planning and conducting internal compliance audits of all operations within the facility.

    Hosts external auditors during site inspections

    Provides support with company and regulatory agency (i.e. DEA, FDA) inspections

    Follow up on audits to assure that action plans are developed and completed in a timely fashion.

    Assist with management review and associated metrics for the plant

    Provides support in the metrics collection and analysis for compliance-related corrective and preventive actions (CAPA's)


    Supports/leads product significant events and market action activities and drafts/reviews all necessary documentation and correspondences between AbbVie-Branchburg, corporate, and regulatory agencies as required.


    Manages the assessment process for new or revised external standards/regulations for applicability and impacts to the Branchburg Quality Management System (QMS) and products.

    Reviews/approves assessments completed by other functional areas.

    Supports/Leads Quality assessments of major product/process changes or new markets.

    Identifies and communicates compliance risks to management to ensure appropriate actions are taken to remediate gaps or areas for improvement.

    Complete customer surveys as needed.

    *Bachelor's degree, preferably in science or Engineering, or equivalent work experience is required


    • 3+ years of experience in medical devices, Experience with Class II and/or Class III medical device
    *Experience coordinating recall/market actions

    *Quality Assurance/Regulatory Affairs/Compliance preferred

    *Knowledge of regulations and standards preferred

    *Ability to evaluation quality, production and support areas for compliance to GMPs

    *Ability to identify and investigate problems and help to resolve them

    *Excellent verbal and technical writing skills with the ability to interface effectively cross-functionally and at all levels.

    *Demonstrated leadership skills.

    #J-18808-Ljbffr
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