MasterControl System Admin

3 weeks ago


Exton, United States Beacon Hill Full time

General Responsibilities:

Quality Assurance is a support group to the Operational Departments of Manufacturing, Quality Control and Facilities. The Quality Assurance System Administrator interacts with all functional groups in the organization to ensure compliance to policies and procedures, in addition, assures accurate and compliant release of intermediates and final product.

Responsibilities:

  • Primary responsibility will be to build and enhance Workflows in all the Modules within MasterControl (Document, Training, CAPA, Deviations, Change Control, Vendor Management and Audits)
  • Manage data structure.
  • Create lifecycles within MasterControl to manage organizers, create templates, virtual folders, document numbering series and custom reports.
  • Configure InfoCard types and Subtypes, Global Settings, Collaboration steps, Packet Types, as necessary to meet business needs.
  • Troubleshoot errors. Design E-Forms/Fillable forms within MasterControl for use by personnel.
  • Manage user licenses and user security settings.
  • Conduct annual validation of MasterControl (PQ), submit subsequent report to MasterControl to meet deadlines.
  • Train employees in use of MasterControl
  • Write and revise Quality Systems and MasterControl related SOPs as necessary to maintain compliance.

Assist the Quality Assurance Management in daily operations, as needed:

  • Review Manufacturing Batch Records (Drug Substance/Drug Product/Media Fills/ Prepared Media and Protocol Records). Review and disposition of manufactured Bulk Drug Substance and Drug Product Injection lots. Records to be reviewed for accuracy, completeness, and compliance with effective SOPs.
  • Review of Quality Control testing data against established specifications for compliance.
  • Manage Deviations, Change Controls and CAPAs to closure.
  • Conduct risk-based investigations using problem solving tools.
  • Review equipment Calibration/PM records
  • Review Computer System Validation records
  • Represent Quality Assurance in Management Review Meetings, Material Review Board Meetings and in continual improvement projects as they relate to the Quality Management System and MasterControl.
  • Participate in Regulatory Agency Inspections, as needed.

Computer Skills:

  • To perform this job successfully, an individual must be proficient in MasterControl system administrative functions and ability to implement various Quality Management System modules (Advanced Quality Event Management (AQEM), previously known as Field Base Solutions (CHANGE-CONTROL, DEVIATION, CAPA, AUDIT etc.)

Education:

  • Minimum Bachelor of Science degree in a scientific discipline

Experience:

  • Minimum two years in a similar Quality Assurance or Quality Systems role in the biologics or pharmaceutical industry a plus
  • Familiarity with 21CFR Part 210, 211, ISO 9001 Std. and ICH guidelines is considered a plus.
  • Familiarity with Quality Management Systems (e.g., ISO9001/ISO1485 Std.)
  • Familiarity with Batch Records and controlled documentation
  • Experience in aseptic processing and mammalian cell culture production considered a plus.

Other Skills:

  • Detail oriented
  • Good verbal and technical writing skills
  • Good interpersonal communication skills
  • Must be open to occasional off shift and weekend work.
  • Positive work attitude that supports teamwork and continuous improvement


  • Exton, United States Beacon Hill Full time

    General Responsibilities:Quality Assurance is a support group to the Operational Departments of Manufacturing, Quality Control and Facilities. The Quality Assurance System Administrator interacts with all functional groups in the organization to ensure compliance to policies and procedures, in addition, assures accurate and compliant release of intermediates...


  • Exton, United States Beacon Hill Full time

    General Responsibilities: Quality Assurance is a support group to the Operational Departments of Manufacturing, Quality Control and Facilities. The Quality Assurance System Administrator interacts with all functional groups in the organization to ensure compliance to policies and procedures, in addition, assures accurate and compliant release of...

  • QMS Administrator

    3 weeks ago


    Exton, United States Beacon Hill Full time

    General Responsibilities: Quality Assurance is a support group to the Operational Departments of Manufacturing, Quality Control and Facilities. The Quality Assurance System Administrator interacts with all functional groups in the organization to ensure compliance to policies and procedures, in addition, assures accurate and compliant release of...

  • QMS Administrator

    2 months ago


    Exton, United States Beacon Hill Full time

    General Responsibilities:Quality Assurance is a support group to the Operational Departments of Manufacturing, Quality Control and Facilities. The Quality Assurance System Administrator interacts with all functional groups in the organization to ensure compliance to policies and procedures, in addition, assures accurate and compliant release of intermediates...

  • QMS Administrator

    2 months ago


    Exton, United States Beacon Hill Full time

    General Responsibilities:Quality Assurance is a support group to the Operational Departments of Manufacturing, Quality Control and Facilities. The Quality Assurance System Administrator interacts with all functional groups in the organization to ensure compliance to policies and procedures, in addition, assures accurate and compliant release of intermediates...

  • QMS Administrator

    1 month ago


    Exton, United States Beacon Hill Full time

    General Responsibilities: Do not pass up this chance, apply quickly if your experience and skills match what is in the following description. Quality Assurance is a support group to the Operational Departments of Manufacturing, Quality Control and Facilities. The Quality Assurance System Administrator interacts with all functional groups in the organization...


  • Exton, United States West Pharmaceutical Services Full time

    Requisition ID: 65704- Date: May 2, 2024- Location: Exton, Pennsylvania, US- Department: Quality- Description: **Who We Are**: At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying...


  • Exton, United States Open Systems Technologies Full time

    Infrastructure Engineer is responsible for designing, building, coordinating, and maintaining the IT environment that we need to run internal operations, collect data, develop, and launch digital products, support internal infrastructure hardware, and achieve other business objectives. **Hybrid Work Model Duties / responsibilities Designing, building, and...


  • Exton, United States Open Systems Technologies Full time

    Infrastructure Engineer is responsible for designing, building, coordinating, and maintaining the IT environment that we need to run internal operations, collect data, develop, and launch digital products, support internal infrastructure hardware, and achieve other business objectives.**Hybrid Work ModelDuties / responsibilitiesDesigning, building, and...


  • Exton, United States Open Systems Technologies Full time

    Infrastructure Engineer is responsible for designing, building, coordinating, and maintaining the IT environment that we need to run internal operations, collect data, develop, and launch digital products, support internal infrastructure hardware, and achieve other business objectives.**Hybrid Work ModelDuties / responsibilitiesDesigning, building, and...


  • Exton, United States Groundwater & Environmental Services, Inc. Full time

    Assist network admin team. Cybersecurity checks and administration. Data management (backup, data replication, recovery, etc)Patch management. Software product updates. Enterprise phone system administration. Collaboration solution administration. Co Support Specialist, Technology, Support, Specialist, IT


  • Exton, United States Gambhir Cosmetic Medicine Full time

    Gambhir Cosmetic Medicine is an established practice and ranked 20 in the Nation and #1 in the Philadelphia area. We are a busy cosmetic practice in King Of Prussia seeking front desk/admin in a close knit high paced environment. Seeking someone with a passion for learning, energetic personality, a love of cosmetic medicine and someone who presents...


  • Exton, United States Groundwater and Environmental Svcs. Full time

    **GES has a very exciting career opportunity for a Technology Support Specialist to join our Corporate IT team, located in our Exton, PA office.** **Responsibilities include**: - Assist network admin team - Cybersecurity checks and administration - Data management (backup, data replication, recovery, etc) - Patch management - Software product updates -...


  • Exton, United States Groundwater and Environmental Svcs. Full time

    Job DescriptionJob DescriptionGES has a very exciting career opportunity for a Technology Support Specialist to join our Corporate IT team, located in our Exton, PA office. Our selected candidate will report to the Director of IT and will work in a fast paced, exciting environment.Responsibilities include:Assist network admin teamCybersecurity checks and...


  • Exton, United States Groundwater and Environmental Svcs. Full time

    Job DescriptionJob DescriptionGES has a very exciting career opportunity for a Technology Support Specialist to join our Corporate IT team, located in our Exton, PA office. Our selected candidate will report to the Director of IT and will work in a fast paced, exciting environment.Responsibilities include:Assist network admin teamCybersecurity checks and...


  • Exton, United States RKL Full time

    Success Factors **Responsibilities**: - Manage front desk responsibilities, including welcoming visitors, fielding incoming phone calls, and directing overflow calls from other offices; oversee fax communications in Exton and prepare coffee as needed for guests and meetings. - Collaboratively handle all aspects of mail logistics, such as sorting, sending,...


  • Exton, United States Cushman & Wakefield Full time

    **Job Title** Front Desk Coordinator **Job Description Summary** This position represents the first impression of the organization, making the role crucial in the professional appearance and client service of the company. Establishing and maintaining a positive presence in the reception area by receiving, directing, and assisting visitors in an efficient,...


  • Exton, United States RKL Full time

    The Tax Administrative Assistant provides overall administrative support to the Tax service line and is responsible for organizing and preparing necessary documents for accountants as needed. They ensure tax returns, forms/reports, and various letters adhere to firm standards according to policies and procedures in place. Additionally, the role involves...


  • Exton, United States RSM Solutions, Inc Full time

    Thank you for stopping by to take a look at the Infrastructure Engineer role I posted here on LinkedIN, I appreciate it. Allow me to introduce myself. My name is Tom Welke. I am Partner & VP at RSM Solutions, Inc and I have been recruiting technical talent for over 22 years and been in the tech sector since the 1990s. I say this because I am far more...


  • Exton, United States RSM Solutions, Inc Full time

    Thank you for stopping by to take a look at the Infrastructure Engineer role I posted here on LinkedIN, I appreciate it. Allow me to introduce myself. My name is Tom Welke. I am Partner & VP at RSM Solutions, Inc and I have been recruiting technical talent for over 22 years and been in the tech sector since the 1990s. I say this because I am far more...