• Document Control Supervisor

    Location US-IL-Chicago
    Posted Date 2 months ago(4/13/2018 10:49 AM)
    ID
    2017-2010
    Company
    Adello Biologics, LLC
  • Overview

    Adello Biologics is a privately held, U.S.-based biotechnology company that leads with science to accelerate development and drive manufacturing efficiency. The company's aim is to provide high-quality, affordable biosimilars to patients worldwide. Headquartered in Piscataway, NJ and driven by a team of highly skilled industry veterans, Adello is advancing a strategic pipeline of proteins and complex monoclonal antibodies with lead candidates in oncology and immunology. For more information, visit www.Adellobio.com

     

    Our vision is to make biosimilar medications affordable. We are seeking candidates interested in contributing to a bourgeoning field that has the potential to help millions of patients. As a growing company, Adello Biologics offers real development opportunities for candidates excited to take on responsibility, make an immediate impact and help us achieve our vision. As part of a close knit team, you’ll have the opportunity to work in a unique, high science industry while expanding your career. We are seeking a Document Control Supervisor to be based out of our Chicago, IL location.

     

    Responsibilities

    SUMMARY:

    The Document Control Supervisor, is responsible for overseeing the daily operations and overall functions of the Quality Assurance Document Control activities. These activities include: processing, review, change control, approval, issuance, and archival of Adello's controlled documents and aspects related to the Electronic Documentation System (EDMS). With Manager oversight, this employee is responsible for the design and implementation of Quality driven projects.

     

    Essential Duties and Responsibilities:

    • Assists in the direction and training of assigned personnel.
    • Author, review and approve procedures governing quality systems and any associated change control in compliance with GMP regulations, customer expectations and company policies.
    • Author, assist and provide input to resolve quality investigations and associated CAPAs in a timely manner.
    • Assists change originators in coordinating all aspects related to documents lifecycle.
    • Responsible for identifying and implementing efficiency improvements to the overall document control process.
    • Acts as a backup for the Document Control / Training Manager.
    • Supervise and provide guidance on the following activities:
    • Issuance and control standard operating procedures, test methods, batch records and forms among others.
    • Audit of issued forms, specifications, labels and batch records for reconciliation and timely return.
    • Filing and maintenance of document archives to ensure documents are easily retrievable.
    • Review of controlled documents update to ensure proper formatting.
    • Template management to ensure harmonization among documents within the organization.
    • Tracking and trending lead-times for document change control requests.
    • Weekly status updates to upper management for all pending document reviews and open employee training assignments.
    • Help Desk support to users of the documentation system. This includes creation and monitoring of incident tickets requiring help desk support from the Electronic Document System Administrator.
    • Issue all training documents to employees and provide follow up to ensure training is completed on time.
    • Assign training modules to employees based on job functions.
    • Enter employee training information into the training database.
    • Administer continuous improvements to EDMS
    • Other tasks as requested by management.
    • Perform other duties and responsibilities as delegated by Quality Management.

    Qualifications

    PREREQUISITES:

    Education:

    • Bachelor degree in life sciences, or other related field.

    Experience:     

    • At least 6 years of previous experience in QA Documentation in the biotech or pharmaceutical field is required.
    • 6-8 years working in a GMP regulated industry is required.
    • Previous experience working in a training capacity is desired.
    • Previous experience with electronic document management systems is desired.      

     

    Certifications, Licenses, etc.:

    • MasterControl Electronic Document Management System Operation certification is preferred.

     

    SPECIALIZED KNOWLEDGE AND SKILLS:

    • Must read, write, speak English
    • Relies on experience and judgment to plan and accomplish goals.
    • Ability to work independently or in teams both writing department and cross-functionally. Must be able to organize, plan and manage assigned tasks to bring projects to completion.
    • High level of organizational and time management skills, must be able to effectively prioritize assignments.
    • Ability to effectively present information and respond to questions from groups of manager, business partners, and employees.
    • Demonstrated ability to work in short timelines to consistently meet deadlines.
    • Computer skills including knowledge of Windows, Word, Excel, MasterControl, and database programs.
    • Understanding of the business and manufacturing processes that are supported by documentation system.

     

    WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS:

    General Work Environment:

    • Must be able to work in an open office environment with moderate noise levels and frequent interruptions.
    • Typing and desk work.
    • Must be able to hear and speak clearly enough to participate in highly interactive, fast paced conversations.

    Noise:

    • Standard office environment noise.

    Standing/Lifting:

    • Walking though manufacturing when required
    • No lifting requirements
    • Must be able to spend at least 75% of work time sitting and using standard desktop computer equipment

    Visual:

    • No special requirements

    Stress:

    • High paced demanding environment to meet the documentation needs of the company
    • Ability to work in a calm professional manner in stressful situations

    Travel:

    • Minimal travel will be expected but not exceed 10%.

     

    Adello Biologics, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Adello Biologics, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation and training.

     

    Notice To Agency And Search Firm Representatives

    Adello Biologics is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Adello employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Adello. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed