• Senior Manager, Quality Assurance

    Location US-IL-Chicago
    Posted Date 2 weeks ago(11/5/2018 5:36 PM)
    ID
    2018-2229
    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 Senior Manager, Quality Assurance to be based out of our Chicago, IL location.

    Responsibilities

    SUMMARY:

    The Senior Manager, Quality Assurance is responsible for review, change control, issuance and control of procedures, forms and test methods throughout the organization.  Manages the Document Control System including administering the MasterControl system; works with other functional users to gather and analyze requirements and define process and systems solutions to these requirements using MasterControl. Ensures document retention policies are met. Assists in review and approval of manufacturing batch records and associated data in support of Manufacturing Quality Assurance, and facilitates the batch release process.

     

    Essential Duties and Responsibilities:

    • Issue and control standard operating procedures, test methods, batch records and forms.
    • Prepare change control documentation.
    • Scan all batch records, validation documentation, calibration information, and supporting documentation and post on the company portal.
    • Assist in the facilitation of finished products, meeting GMP requirements. Assist MQA Manager in the release of product through review of manufacturing and testing documentation.
    • Assist in ensuring that products that don’t meet specification are properly investigated prior to disposition.
    • Act as a subject matter expert/Liaison in support to FDA inspections for all responsible areas.
    • Perform regular audit of issued forms and batch records to reconcile and ensure timely return of documents.
    • File and maintain document archives to ensure documents are easily retrievable.
    • Update of procedures and test methods to ensure documents are properly formatted.
    • Responsible for template management to ensure harmonization among documents within the organization.
    • Track and trend lead-times for document change control requests.
    • Submit weekly status updates to upper management for all pending document reviews and open employee training assignments.
    • Provides 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.
    • Assists change originators in coordination of document releases.
    • Responsible for identifying and implementing efficiency improvements to the overall document control process.
    • Manages reporting staff within the Document Control Department.
    • Ensures timely processing of document change requests through the Document Control Department.
    • Ensure clear departmental procedures and effective training of departmental staff.
    • Support change control activities in terms of ensuring the proper standards and processing of item types through MasterControl.
    • Lead and actively participate in all phases of the system evolvement including gathering requirements to functional and technical specifications testing and implementation of MasterControl.
    • Responsible for performing systems analysis and applications configuration of MasterControl application.
    • Work with cross functional teams to test and implement patches and changes to applications environment.
    • Validate and document MasterControl configuration changes to be complaint with CFR Part 11.
    • Utilize reports, interfaces, customizations, extensions and workflows to meet business requirements.
    • Perform other duties and responsibilities as delegated by Quality Management.

    Qualifications

    PREREQUISITES:

    Education:

    • A Bachelor’s degree in life science, computer science, or other related field; or commensurate experience (7+ years) in a document control capacity, preferably in cGMP regulated industry

    Experience:      

    • Previous experience with electronic document management systems is desired.  Experience commensurate with position level.
    • Previous experience with the review and approval of batch records for the production of drug substances, drug substance intermediates and drug products.
    • Previous work in a cGMP industry is desired.

    Certifications, Licenses, etc.:

    • MasterControl™ Electronic Document Management System Operation certification is preferred.

     

    SPECIALIZED KNOWLEDGE AND SKILLS:

    Language:

    • Must read, write, and speak English

    Mathematical Skills:

    • Not required

    Reasoning Skills:

    • Relies on experience and judgment to plan and accomplish goals.

    Computer and/or Technical Skills:

    • High level of organization skills.
    • Ability to write procedures.
    • 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.
    • Understanding of the business and manufacturing processes that are supported by documentation system.
    • Computer skills including knowledge of Windows, Word, Excel, MasterControl™, and database programs.

       

    WORK ENVIRONMENT AND PHYSICAL DEMANDS:

    General Work Environment:

    • Must be able to work in an open office environment with moderate noise levels and frequent interruptions.
    • 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 to exceed 5% for external training/events at MasterControl headquarters in Utah.

     

    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.

     

     

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