• Quality Control Associate I

    Job Locations US-MA-Watertown
    Job ID 2018-1042
  • Overview

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

     

    Assist in all aspects of quality control in respect to clinical trial materials and commercial products as required. This position provides QC support to the Development, Operations, QA/QC, and Regulatory Affairs departments.

    Responsibilities

    • Receive GMP and/or technical training and provide such training to colleagues when required. Assure and apply current good manufacturing practice (cGMP) including good documentation practice (GDP) throughout laboratory operations.
    • Adhere to the GMP Quality Management System (QMS) currently in place to ensure compliance with documented policies and procedures.
    • Prepare reagents and standards per procedure.
    • Perform testing of raw materials and final products by following analytical methods.
    • Perform sample management and incoming quality assurance (IQA) verification of raw materials, as required.
    • Operate instruments in supporting of all analytical assays, and ensure the equipment are properly calibrated and maintained.
    • Perform routine Laboratory housekeeping to ensure the maintenance and compliance of laboratory’s operational areas.
    • Track and test products according to Stability Program’s schedule and protocols.
    • Identify laboratory anomalies and/or discrepancies then notify QC Manager in a timely manner.
      • Conduct or support QC Manager with investigations regarding out-of-trend (OOT)/out-of-specification (OOS) results, or Environmental Alert/Action Report (EAR).
      • Address and manage deviations related to analytical procedures.
      • Provide update of OOT/OOS/EAR/Deviation at weekly meeting.
    • Use SOPs, WIs, Specifications, Trends, other applicable references and expertise to propose solution(s) to 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.
    • Participate in group and/or project teamwork for project and process improvements.
    • Support internal and external audits and regulatory inspections, as required.
    • Perform other duties as requested/assigned by Quality Management to support Quality activities.

    Qualifications

    Education

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

    Work Experience

     

    • 1–3 years of demonstrated practical Quality Control experience in GMP regulated laboratory
    • Working knowledge of High Performance Liquid Chromatography (HPLC) and Spectroscopy
    • Working knowledge of Environmental Monitoring (EM) and other microbiological assays such as: endotoxin, bioburden, sterility, etc.

    Requirements

    • Self-motivated, strong work ethic, organizational skills, communication skills, critical thinking, attention to detail and accuracy, the ability to work independently and in a team environment, are essential.
    • Good verbal and written skills.
    • Basic 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 and keeping QC Manager informed of status.
    • 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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