• Quality Control Manager

    Job Locations US-MA-Watertown
    Job ID 2018-1041
  • Overview

    Manage the GMP QC laboratory to ensure that all products are tested for both analytical and microbiological assays, and test results are reviewed and approved for release in accordance with company’s procedures and applicable GMP regulations and guidelines (e.g. 21CFR Parts 11, 210/211, 820, (USP/EP/JP), ICH Guidelines, etc.).

     

    Manage QC’s day-to-day activities which include all aspects of quality control to support release of clinical trial materials and commercial products, as required.  This position will interact with cross-functional colleagues from Development, Operations, QA/QC, and Regulatory Affairs departments.

    Responsibilities

    • Provide GMP and/or technical training to QC staff when required.
    • Ensure current good manufacturing practice (cGMP) including good documentation practice (GDP) are followed throughout laboratory operations.
    • Adhere to GMP Quality Management System (QMS) currently in place to ensure compliance with documented policies and procedures.
    • Manage and responsible for overall GMP QC laboratory to ensure the following tasks are performed by QC staff:
      • testing of raw materials and final products by following analytical methods.
      • performing sample management and incoming quality assurance (IQA) verification of raw materials, as required.
      • operating instruments in supporting of all analytical assays, and ensure the equipment are properly calibrated and maintained.
      • performing routine Laboratory housekeeping to ensure the maintenance and compliance of laboratory’s operational areas.
      • tracking and testing products according to Stability Program’s schedule and protocols.
    • Conduct investigations regarding out-of-trend (OOT)/out-of-specification (OOS) results, or Environmental Alert/Action Report (EAR).
      • addressing and managing deviations related to analytical/microbiological procedures.
      • providing update of OOT/OOS/EAR/Deviation at weekly team meeting.
      • applying SOPs, WIs, Specifications, Trends, and technical expertise to troubleshoot and resolve laboratory issues.
    • Develop, revise and review SOPs, Specifications, Qualification/Validation protocols and reports, as appropriate.
    • Work with internal and external resources to maintain laboratory in an optimal and compliance state, (e.g. coordinate with internal stakeholders to support operational activities, or coordinate with external vendors to support calibration/preventive maintenance activities, etc.)
    • Plan and perform workload to meet schedules, timelines, deadlines as per procedure’s and/or department requirements.
    • Lead or participate in project team for project and process improvement initiatives.
    • Monitor and trend data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release.
    • Generate CoAs for product release.
    • Identify gaps in systems and procedures. Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
    • Assist in the preparation of dossiers and QC data packages for interactions between EyePoint Pharma and Regulatory agencies, when required.
    • Support internal and external audits and regulatory inspections, as required.
    • Participate as Subject Matter Expert (SME) during Regulatory Inspections, as appropriate.
    • Perform other duties as assigned by Quality Management to support Quality activities

    Qualifications

              Education

                   BS/BA or MS degree in science or an equivalent combination of education and experience in related field of pharmaceutical or biopharmaceutical industry.

     

    Work Experience

      • 7–10 years of demonstrated practical Quality Control experience in GMP regulated laboratory
      • Working knowledge of High Performance Liquid Chromatography (HPLC) and Spectroscopy;

    Gas Chromatography (GC) or Thin Layer Chromatography (TLC), considered a plus

      • Working knowledge of Environmental Monitoring (EM) and other microbiological assays such as: endotoxin, bioburden, sterility, etc.

    Requirements

    • Self-motivated, strong work ethic, strong organizational skills, strong communication skills, critical thinking, attention to detail and accuracy, the ability to work independently and in a team environment, are essential.
    • Strong verbal and written skills.
    • Working knowledge of GMP documentation and application of principles, theories and practices of the analytical chemistry and/or microbiological, is required.
    • Routinely exercises sound judgment, reasoning and problem solving.
    • Capable of timely completing assigned responsibilities under minimal supervision.
    • Flexible and able to respond quickly to shifting priorities and meet deadlines.
    • Position may involve use of reagents and other chemical compounds that are considered hazardous.
    • Proficiency with Microsoft Office tools (Excel, Word, PowerPoint, Outlook).
    • Ability to work and interact with all departments at EyePoint Pharma.
    • Ability to communicate and work independently with scientific/technical personnel in both internal and external setting.

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