Agenus

  • Quality Assurance Senior Specialist

    Job Locations US-MA-Lexington
    Job ID
    2018-1371
    Category
    Quality
  • Overview

                       

    The Senior Specialist of Quality provides direction, support, and guidance to our Lexington, MA facility. This role will manage, coordinate, and monitor in conjunction with the Manager of Quality to ensure that all quality objectives are met. The Senior Specialist of Quality assists the Quality team in overseeing all quality system-driven activities and demonstrates a high level of involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained.

    Roles and responsibilities:

    Coordinate, maintain, and further enhance Quality Assurance Systems as related to product quality and responsible for adhering to GMP regulations, cGMP’s, and company policies. Facilitates Quality Assurance Systems process functions to support compliance and Product Release. Responsibilities include:

    • Assure cGMP’s and company procedures are followed and, if needed, procedures/policies are revised.
    • Assist and collaborate with other department such as Manufacturing, Quality Control, Clinical Operations, Regulatory, and Pharmacovigilance to ensure continued compliance, product quality, and patient safety. Troubleshoot issues related to quality concerns, implementing effective solutions and corrective actions.
    • Identify opportunities for process and system improvement and enhancement.
    • Participate in quality and process improvement initiatives and project teams.
    • Creates metrics for the assigned areas of responsibilities to ensure performance is monitored and actions are taken when required for continuous quality system improvements.

     

    • Enhance and maintain documentation control processes and systems:
      • Assess document packets in electronic document management system to ensure compliance to applicable procedures, including document template, reviewer selection, appropriate change justification, etc.
      • Maintain appropriate chain of custody for controlled documents submitted for archival.
      • Maintain archive database for accuracy of documentation details and location.
      • Retrieval of documentation upon internal customer request and during inspection activities.
      • Prepare and coordinate documentation transfer to offsite archive.
      • Quality documentation processing in support of ongoing projects and daily GxP operations.
      • Management of document archive program.
      • Support and advise end users on document system requirements and workflows.
      • Documentation metrics reporting.
      • Issuance of batch records and labels

     

    • Enhance and maintain quality operational control processes and systems:
      • Complete routine batch history record review consisting of the executed batch record and all associated Quality Control data to meet pre-defined timelines.
      • Review temperature monitoring related data for equipment used in cGMP processes.
      • Review equipment Calibration and Maintenance records

     

    • Enhance and maintain quality system processes and systems:
      • Reviews and approves internal CAPAs, Change Controls, Investigations, Deviations, and other quality systems to aid in timely product release and quality system closure.
      • Assists in Product Complaint investigations, Material, Change Management Review Boards as needed.

     

    ·         Additional Duties as Assigned:

    ·         Internal and External audit support.

    ·         Third party and regulatory inspection participation and support.

    ·         Assists with the creation and roll out of ongoing Inspection Readiness activities.

    ·         May participate in software system upgrade activities, such as testing and validation.

     

     
     
     
     
     

                                                                                 

    Responsibilities

    Roles and responsibilities:

    Coordinate, maintain, and further enhance Quality Assurance Systems as related to product quality and responsible for adhering to GMP regulations, cGMP’s, and company policies. Facilitates Quality Assurance Systems process functions to support compliance and Product Release. Responsibilities include:

    • Assure cGMP’s and company procedures are followed and, if needed, procedures/policies are revised.
    • Assist and collaborate with other department such as Manufacturing, Quality Control, Clinical Operations, Regulatory, and Pharmacovigilance to ensure continued compliance, product quality, and patient safety. Troubleshoot issues related to quality concerns, implementing effective solutions and corrective actions.
    • Identify opportunities for process and system improvement and enhancement.
    • Participate in quality and process improvement initiatives and project teams.
    • Creates metrics for the assigned areas of responsibilities to ensure performance is monitored and actions are taken when required for continuous quality system improvements.

     

    • Enhance and maintain documentation control processes and systems:
      • Quality documentation processing in support of ongoing projects and daily GxP operations.
        • Assess document packets in electronic document management system to ensure compliance to applicable procedures, including document template, reviewer selection, appropriate change justification, etc.
      • Management of document archive program.
        • Maintain appropriate chain of custody for controlled documents submitted for archival.
        • Maintain archive database for accuracy of documentation details and location.
        • Retrieval of documentation upon internal customer request and during inspection activities.
        • Prepare and coordinate documentation transfer to offsite archive.
      • Support and advise end users on document system requirements and workflows.
      • Documentation metrics reporting.
      • Issuance of batch records and labels

     

    • Enhance and maintain quality operational control processes and systems:
      • Complete routine batch history record review consisting of the executed batch record and all associated Quality Control data to meet pre-defined timelines.
      • Review temperature monitoring related data for equipment used in cGMP processes.
      • Review equipment Calibration and Maintenance records

     

    • Enhance and maintain quality system processes and systems:
      • Reviews and approves internal CAPAs, Change Controls, Investigations, Deviations, and other quality systems to aid in timely product release and quality system closure.
      • Assists in Product Complaint investigations, Material, Change Management Review Boards as needed.

     

    ·         Additional Duties as Assigned:

    ·         Internal and External audit support.

    ·         Third party and regulatory inspection participation and support.

    ·         Assists with the creation and roll out of ongoing Inspection Readiness activities.

    ·         May participate in software system upgrade activities, such as testing and validation

    Qualifications

    • Bachelor's Degree in science or related field and 6+ years of successful quality assurance related experience.
    • Knowledge of relevant laws, legal codes, government regulations and agency rules. Includes the understanding of cGMP requirements, GxP regulations and current industry practices.
    • Comprehensive knowledge of quality principals and systems, audit, manufacturing processes, procedures and equipment within a pharmaceutical biologic environment. 
    • Demonstrated critical problem-solving skills with ability to coordinate process improvement initiatives and quality system related projects with high level / wide scope and complexity.
    • Demonstrated ability to effectively communicate information and ideas to interact effectively with peers, senior management, regulatory officials, auditors, contractors and consultants.
    • Knowledge of computer software, including relevant applications such as MS Word, Excel, PowerPoint, Box, and Dropbox
    • Experience with an electronic QMS tool, MasterControl preferred.
    • Preferred Skills:

      • MasterControl electronic QMS experience preferred.
      • Competencies Needed:

        • Candidate must be able to perform functions under minimum supervision. Receive general instructions on new work; refers to policies and practices for guidance. Work is reviewed for technical soundness and accuracy.
        • Ability to balance short and long-term goals and to prioritize appropriately to support company goals.
        • Evaluates continuous improvement actions keeping abreast of relevant scientific, regulatory and business environments.

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