• Quality Control Specialist III, QC Compliance

    Location US-IL-Chicago
    Posted Date 3 weeks ago(3 weeks ago)
    ID
    2018-2189
    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 Quality Control Specialist III, QC Compliance to be based out of our Cicago, IL location.

    Responsibilities

    SUMMARY:

    This position a full-time, exempt position at Adello Biologics, LLC at its Chicago, IL manufacturing facility. The employee will responsible for supporting Adello’s stability program as well as assist in related compliance activities.

     

    Essential Duties and Responsibilities

    • Writes, revises, and reviews standard operating procedures (SOPs) and test methods.
    • Manage all GMP stability data generated from the Chicago site – assists in the preparation of stability protocols and data summary reports, monitors data trends , establish / extend product retest and expiration intervals.
    • Establish and monitor stability test schedules to ensure timely performance of stability testing in compliance with approved protocols.
    • Investigate product release and stability deviations and /or trends in results, and report such deviations to Senior Management.
    • Author stability test protocols and interim and end-of-study reports for completed stability testing, in compliance with approved protocols.
    • Remain current on industry trends and regulatory guidance documents (FDA, EU Annex, ICH, etc.)
    • Set up tracking and trending metrics for stability testing data.
    • Conduct reviews of release testing, stability testing, raw material testing, method validations, equipment qualifications and calibrations, technical protocols and reports to ensure compliance with internal procedures and policies, good distribution practices (GDPs), current good manufacturing practices (cGMP), ICH, and other applicable regulations.
    • Facilitates, reviews, and provides input on lab investigations, deviations, and CAPAs.
    • Independently set-up, maintain, operate and perform routine calibration on laboratory equipment including, but not limited to, analytical balances, pH meters, HPLC and UPLC, etc.
    • Create compliance-related training material and train staff.
    • Performs or assists with lab audits.
    • Implements and manages systems.
    • Provides ideas to drive efficiency.
    • Assists in the direction and training of other team members.
    • Has familiarity with FDA guidelines for biosimilar, USP, cGMP, Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines, and ICH guidelines.
    • Assures that test batch records and deviations, OOS results, QA audits, and other paperwork are completed according to cGMPs and company SOPs.
    • Other duties as requested by management.

    Qualifications

    PREREQUISITES:

    Education:

    • A bachelor’s degree or a master’s degree in life science (Biology, Analytical Chemistry, etc.).

    Experience:

    • Previous laboratory experience as an analyst/Sr.scientist is preferable.
    • Previous experience (11-15 years) in cGMP pharmaceutical manufacturing environment is required.
    • Working knowledge of cGMP regulations is required.

     

    SPECIALIZED KNOWLEDGE AND SKILLS:

    • In depth understanding and technical knowledge of laboratory calibration processes, especially with HPLC and UPLC.
    • Strong communication skills, both written and verbal.
    • Knowledge of LIMS preferred.
    • Must be able to effectively manage time to complete assignments.
    • Excellence computer skills in Microsoft Office applications.

     

    WORK ENVIRONMENT AND PHYSICAL DEMANDS:

     

    General Work Environment:

    • General office environment in an open office set-up.
    • Significant amount of time sitting and significant computer use.
    • Strong ability to work independently and as team member under the pressure of manufacturing.

     

     

    Noise:

    • Noise level accompanying an open office set-up.

     

    Standing/Lifting:

    • No special standing or lifting requirements.

     

    Visual:

    • No special requirements.

     

    Stress:

    • High paced demanding environment to meet ambitious project goals.

     

    Travel:

    • No travel 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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