Jobs
>
Rochester

    Site Quality Systems Specialist - Rochester, United States - Visron Technical

    Default job background
    Description
    *JOB SUMMARY:

    The Quality Systems Specialist is responsible for managing all site inspections including regulatory agency inspections, customer audits and internal self-inspections.

    This position will support regulatory agency and customer audits by facilitating the 'Front Room' activities, writing the audit responses, and tracking all CAPA's associated with the responses.

    The role is responsible for managing the site risk assessment process including the identification of risk, evaluation of deficiencies, training and coaching on the risk process.

    The specialist will be responsible for the oversight of the site change control system which will include facilitation of the change control committee meetings, training, and coaching site employees on the change control process.

    In addition, the Quality Systems Specialist will support on-going continuous improvement activities of the site's Pharmaceutical Quality System.

    *DUTIES /


    RESPONSIBILITIES:

    • Manage regulatory inspections and customer audits
    • Coordinate with area managers to ensure the site is 'inspection ready' in each of the areas by monitoring the site during regular site visits
    • Ensure adequate preparation for all regulatory inspections, customer, and internal audits to include documentation and site personnel
    • Lead the 'Front Room' activities for all customer audits
    • Assist with front room facilitation for regulatory inspections, when required
    • Involve other site personnel as appropriate depending on the number of inspectors/auditors
    • Act as SME for the responsible areas as described in the job summary and address inquiries as appropriate
    • Coordinate the 'Back Room' activities during Regulatory Inspections, when required
    • Compose the formal responses to the audit observations with the assistance of area managers or designees
    • Ensure follow-up of the corrective action plans initiated after customer audits and regulatory inspections
    • Document all inspection activities within the TrackWise system according to required timelines
    • Facilitate the self-inspections management process
    • Perform risk analysis to determine the content and schedule of the annual internal audits
    • Formalize the audit schedule ensuring that all six systems in the inspection model are considered including quality, production, facilities and equipment, laboratory controls, materials, and packaging/ labeling
    • Ensure adherence to the audit schedule, audit reporting, classification of deviations, development of responses and the implementation of actions
    • Provide continuous training for the internal audit team and facilitate professional training when necessary
    • Identify risk and evaluate deficiencies while working with internal departments/business units for remediation
    • Provide risk assessment training to site personnel, create, review, and/or approve risk assessments
    • Evaluate the change control system and provide continuous improvement ideas
    • Monitor the system to ensure that all stakeholder approvals, final approvals, actions items and closures progress according to timelines
    • Review and approve all documents associated with the activities of the job description
    • Write procedures, protocols, reports, risk assessments applicable to the area
    • Assist in procedure, protocol and report writing as necessary
    • Support on-going continuous improvement activities of the site's Pharmaceutical Quality System
    *EDUCATION/ QUALIFICATIONS/EXPERIENCE:
    • Bachelor's Degree in Life Sciences or related field
    • Minimum 3 – 5-year experience in FDA regulated environment, preferably in a pharmaceutical manufacturing setting

    INDHP

    Job Types:
    Full-time, Permanent


    Pay:
    $73, $80,000.00 per year


    Benefits:

    • 401(k)
    • 401(k)
    matching

    • Dental insurance
    • Health insurance
    • Life insurance
    • Paid time off
    • Vision insurance

    Experience level:

    • 4 years

    Schedule:

    • 8 hour shift
    • Monday to Friday

    Work setting:

    • In-person
    • Manufacturing facility

    Education:

    • Bachelor's (Required)

    Experience:

    • Manufacturing: 4 years (Required)
    • FDA regulations: 4 years (Required)
    *CAPA: 4 years (Required)

    • Quality audits: 4 years (Required)

    Work Location:
    In person %5803407% %%manufacturing%%


  • Akkodis Rochester, United States

    Job Description · Job DescriptionAkkodis currently has a Senior Systems Administrator position with a client located in Rochester, NY. Cannot use agencies with this position. This is a Direct Hire position, and it is a hybrid model with on-site and working remotely. The person ne ...


  • Akkodis Rochester, United States

    Akkodis currently has a Senior Systems Administrator position with a client located in Rochester, NY. Cannot use agencies with this position. This is a Direct Hire position, and it is a hybrid model with on-site and working remotely. The person needs to live within 60 miles of Ro ...


  • Eastman Kodak Company Rochester, United States

    Kodak is Hiring · Eastman Kodak Company is looking for a Controls Systems Specialist to join our team in Rochester, NY. We are seeking an individual with the background to be successful supporting our ESTAR Manufacturing Operations located within Eastman Business Park in Rocheste ...


  • Kodak LTD. Rochester, United States

    Role Overview · Eastman Kodak Company is looking for a Control System Specialist to join our team in Rochester, NY. We are seeking an individual with the background to be successful supporting our ESTAR Manufacturing Operations located within Eastman Business Park in Rochester, ...


  • Akkodis Rochester, United States

    Job Description · Job DescriptionAkkodis currently has a Senior Systems Administrator position with a client located in Rochester, NY. Cannot use agencies with this position. This is a Direct Hire position, and it is a hybrid model with on-site and working remotely. The person ne ...


  • Army National Guard Rochester, United States Full time

    Job Description · Communication is the pulse of Army National Guard units, and it's up to the Signal Support Systems Specialist to ensure the information keeps flowing so the military doesn't miss a beat. · Signal Support Systems Specialists are responsible for integrating signa ...


  • Harris Rochester, United States Full time

    Your purpose of your role as a Building Automation System Specialist II · As a BA System Specialist, you will primarily perform and develops sequence testing, project graphics, and point to point verification ensuring the system runs as efficiently as possible. Work as a part of ...


  • Siemens Corporation Rochester, United States

    Here at Siemens, we take pride in enabling sustainable progress through technology. We do this through empowering customers by combining the real and digital worlds. Improving how we live, work, and move today and for the next generation We know that the only way a business thriv ...


  • Visron Technical Rochester, United States

    Our client is a world leading contract development and manufacturing organization of pharmaceutical products. Located in France, the USA, Brazil, and China, we provide comprehensive innovation & development services to fulfil every aspect of contract pharmaceutical manufacturing ...


  • Cynet Systems Rochester, United States

    Job Description · Job DescriptionWe are looking for HVAC Controls System Specialist for our client in Rochester, NY · Job Title: HVAC Controls System Specialist · Job Location: Rochester, NY · Job Type: Contract · Job Description: · Pay Range $96.40hr - $101.40hr · Responsibiliti ...


  • Harris Rochester, United States Full time

    Your purpose of your role as a BAS / Controls System Specialist · As a Controls System Specialist, you primarily control operational verification testing and point to point verification ensuring the system runs as efficiently as possible. This position works as a part of a team ...


  • Unifin SAS Rochester, United States

    Quality Systems Specialist · Who we are? · We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify patients' lives to as many people as possible. · With 30 years of technological expertise, we position ours ...


  • Eastman Kodak Rochester, United States

    Kodak is Hiring · Want to make an application Make sure your CV is up to date, then read the following job specs carefully before applying. · Eastman Kodak Company is looking for a Controls Systems Specialist to join our team in Rochester, NY. We are seeking an individual with ...


  • L3Harris Technologies Rochester, United States

    This Chief Systems Engineer will lead technical concept and architectural design development activities for Tactical Communication products, informed by interaction with both internal and external customers. The candidate will be required to provide Systems Engineer, Engineer, Sp ...


  • Harris Geospatial Solutions Rochester, United States

    Job Title: Chief Systems Engineering Sr. Specialist · Job Code: 11206 · Job Location: Rochester, NY · Job Schedule: 9/80: Employees work 9 out of every 14 days – totaling 80 hours worked – and have every other Friday off · Job Description: · This Chief Systems Engineering Sr. Spe ...


  • L3Harris Technologies Rochester, United States Temps plein

    Job Title: Chief Systems Engineering Sr. Specialist · Job Code: 11206 · Job Location: Rochester, NY · Job Schedule: 9/80: Employees work 9 out of every 14 days – totaling 80 hours worked – and have every other Friday off · Job Description: · This Chief Systems Engineering Sr. Spe ...


  • Harris Geospatial Solutions Rochester, United States

    Job Description: · This Chief Systems Engineer will lead technical concept and architectural design development activities for Tactical Communication products, informed by interaction with both internal and external customers. The candidate will be required to provide technical s ...


  • L3Harris Technologies Rochester, United States

    Job Title: Chief Systems Engineer · Job Code: 11206 · Job Location: Melbourne, FL · Job Schedule: 9/80: Employees work 9 out of every 14 days – totaling 80 hours worked – and have every other Friday off · Job Description: · This Chief Systems Engineer will lead technical concept ...


  • Army National Guard Rochester, United States

    Job Description · Communication is the pulse of Army National Guard units, and it's up to the Signal Support Systems Specialist to ensure the information keeps flowing so the military doesn't miss a beat. · Signal Support Systems Specialists are responsible for integrating sign ...


  • L3Harris Technologies Rochester, United States

    Job Title: Chief Systems Engineering Sr. Specialist · You could be just the right applicant for this job Read all associated information and make sure to apply. · Job Code: 11206 · Job Location: Rochester, NY · Job Schedule: 9/80: Employees work 9 out of every 14 days – total ...