• Specialist II, Quality Systems & Internal Operations

    Location US-IL-Chicago
    Posted Date 2 weeks ago(11/5/2018 9:54 AM)
    ID
    2018-2227
    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 Specialist II, Quality Systems & Internal Operations to be based out of our Chicago, IL location.

    Responsibilities

    SAMMURY:

    The Specialist II, Quality Systems & Internal Operations is a regular employee in a full-time position at Adello Biologics, LLC, in Chicago, IL. In this role, employee will be responsible for supporting Adello Quality Assurance management in implementing and managing the quality system to ensure overall product and process quality. As an integral quality team member, individual’s job activities provides assurance that all products and quality system processes in the facility are in compliance with cGMP requirements and company policies and procedures and assists in the direction and training of other quality team members. Position involves reviewing and assembling batch documentation, issuing and tracking controlled documents, reviewing raw material documentation and releasing material, reviewing facility preventive maintenance and calibration records. Position also involves the completion of manufacturing clearance activities to ensure requirements are met prior to and upon completion of manufacturing activities and to serve as the witness for critical steps in manufacturing records and quality control documents.

     

    Essential Duties and Responsibilities:

    • Issue and review of documentation supporting batch, laboratory, warehouse, and metrology activities to ensure complete and in compliance with company policies and procedures and cGMP requirements.
    • Perform quality assurance walk-through audits of manufacturing, laboratory and warehouse areas to ensure compliance with cGMPs and company procedures.
    • Quality support of environmental/quality monitoring and release of controlled systems and environments. Support includes data review for release and support of investigation activities.
    • Provide back up for other Quality Assurance Specialist responsibilities.
    • Assist and provide input as part of a project team to resolve quality and manufacturing issues and identify and implement corrective and preventive actions in a timely manner.
    • Manage a broad spectrum of projects to support the needs of Quality Management.
    • Perform other duties and responsibilities as delegated by Quality Management.

    Qualifications

    PREREQUISITES:

    Education:

    • A 4-year Bachelor degree, preferably in science or engineering discipline

    Experience:

    • Previous experience in cGMP pharmaceutical manufacturing environment is desired (2-3 years).
    • Working knowledge of cGMP regulations (21 CFR210/211/820) is desired.

     

    SPECIALIZED KNOWLEDGE AND SKILLS:

    • Good communication skills, both written and verbal.
    • Good organizational skills and detail oriented. Must be able to effectively manage time to complete assignments.
    • Excellent computer skills in Microsoft Office applications.

     

     

    WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS:

    • Typing, desk work and plant auditing 8-10 hours/day.
    • Must be able to read, write and understand English.
    • Some brief and/or minimal exposure to hazardous chemicals may occur, requiring personal protective equipment.
    • Safety alertness is required due to work around hazardous equipment and conditions.
    • Travel not required.

     

    General Work Environment:

    • Manufacturing clean rooms
    • Willing to work in any of the three shifts or rotate Shifts and work weekends as required by the Operations.

     

    Noise:

    • Standard noise levels.

     

    Standing/Lifting:

    • Extended periods of standing and walking while working in the manufacturing areas
    • Must be able to lift 25 lbs.

     

    Visual:

    • Eye test for prescription safety glasses is required.

     

    Stress:

    • High paced demanding environment to meet the Manufacturing needs of the company
    • Excellent interpersonal skills.

     

    Travel:

    • None Required

     

     

    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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