• Manager QC

    Job Locations US-FL-Miami
    Job ID
    2018-1312
    # of Openings
    1
    Type
    Full Time Regular
    Category
    Quality
    FLSA Status
    Exempt
    Work Shift
    N/A
  • Overview

    The Quality Control department is responsible for support of the Manufacturing department and external customers. The primary functions of the laboratory are raw material, in-process, finished product and stability testing.  Laboratory testing encompasses assays performed on raw materials and drug product at various stages to determine product safety and quality.

    This position is responsible for activities relating to the daily function of the Quality Control laboratory and strategic planning for the laboratory and laboratory staff. The individual is the subject matter expert on analytical testing. The individual is heavily involved in partner and regulatory audits, site metrics meetings, site-wide improvement projects, budgeting and data review and interpretation, including protocols, investigations, and laboratory documentation. This position is responsible for the entire laboratory team, and is required to perform staff management duties such as reviews, disciplinary action, and ensure training is performed. The individual operates with very limited supervision and must be able to work both independently and on teams.

    Responsibilities

    • Embraces a "team" working environment focused on achieving department goals by demonstrating willingness to accept assignments not specifically listed in the job description as allowed by the limitations of training, experience, and/or education.
    • Adheres to safety rules and awareness, demonstrates good safety practices at all times. Takes initiative to report and correct safety hazards. Uses Personal Protective Equipment (PPE) associated with assigned tasks.
    • Demonstrates and promotes the values of accountability, communication, customer commitment, entrepreneurial spirit, integrity, safety and teamwork.
    • Executes against project plans and goals as assigned by Quality Management.
    • Meets productivity, quality and teamwork metrics for level.
    • Performs all assigned tasks according to applicable camps and internal written procedures.
    • Follows strict good documentation practices per company's SOP and cGMP regulation.
    • Actively completes assigned training activities and documents training within assigned time frames and before performing any activity associated with the training topic.
    • Functions as a subject matter expert within the analytical laboratory and provides support at all times.
    • Monitors laboratory resources, identifies/reports resource gaps, and assists in recruiting, screening, procuring, and/or qualifying needed resources.
    • Works independently and is able to facilitate non-routine assignments.
    • Mentors and develops staff to maximize staff performance and objectives.
    • Works in collaboration with other departments to evaluate and recommend improvements to analytical methods associated with validation, transfer, or review activities.
    • May manage inter-departmental projects to ensure timely completion of objectives.
    • Maintains utmost level of confidentiality at all times
    • Performs instrument/method troubleshooting within analytical method parameters.
    • Writes, revises, reviews, and implements technical documentation including protocols, reports; reference standard qualification reports; analytical test procedures; and change controls.
    • May review analytical testing records/logbooks for compliance with cGMPs, compendial requirements, and Noven procedures/protocols.
    • Reviews and/or writes technical reports, procedures, investigations and protocols.
    • Provides problem solving skills to support the resolution and documentation of investigations for laboratory and manufacturing issues
    • Draws conclusions from data and communicates those conclusions is writing.
    • Determines root causes of non-conformance and recommends corrective action. Ensures timely closure of investigations.
    • Documents, develops and applies strategies to ensure achievement of scientific objectives by monitoring/ evaluating the completion of tasks.
    • Establishes policies, procedures, and practices associated with laboratory activities including safety, testing, scheduling and documentation.
    • Maintains and improves GMP compliance and documentation.
    • Schedules laboratory testing and associated activities to minimize operational disruptions to departments.
    • Performs training and supervises staff in use of instrumentation and testing techniques, protocols, procedures, cGMPs, and regulated safety guidelines.
    • Performs annual review of data generated by the Quality Control Laboratory. Generates data figures and trends. Presents and evaluates annual results to the Quality Management.
    • May perform internal audits of Quality Control.
    • May perform external audits of vendors with respect to laboratory GMP’s.
    • Assist with QC Director duties such as attending meetings in the absence of the Director
    • Determine and maintain laboratory budget.

    Qualifications

    Competencies:

     

    Education / Experience:

    Bachelor’s degree in chemistry.  Seven or more years of professional experience.  Broad knowledge of scientific principles and methods, wet chemistry, chromatographic analysis, analytical methods (i.e., HPLC, GC, UV), and an understanding of separation theories.  Good written and verbal communication skills; highly organized.  PC literate with basic knowledge of MicroSoft office application software.

     

     

    Judgment / Decision Making:

    Under general direction toward broad assignments with periodic reviews.  Duties performed within a framework of departmental or functional protocol requiring a high degree of original thinking.

                   

     

    Work Environment:

    Laboratory environment with exposure to chemicals, caustics, fumes, electrical current, and odors.

     

     

     

    Physical Demands:

    Visual acuity and manual dexterity required to operate computer and proofread documents.

                   


     

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