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    Team Leader Quality - Tampa, United States - Bausch & Lomb

    Bausch & Lomb
    Bausch & Lomb Tampa, United States

    1 week ago

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    Description

    **Team Leader Quality**

    **Location:** US-FL-Tampa, Florida, US Objectives/Purpose of Job:

    Supervise and coordinates activities and resources associated with Stability department including annual stability program, annual product review, regulatory filing, development activities, GOE Expansion, and investigations/CAPA activates. Responsible for identification of relevant product trends, with emphasis on prevention and proactive management of potential future issues.

    This Quality position oversees stability team members and supports a pharmaceutical manufacturing environment through the application of various statistical procedures, methods, and tools and analyze data and generate reports to support product development, registration and modification to filing and marketed product shelf life via annual product review process or planned changes.

    Work is performed in an office/ laboratory and/or warehouse environment. This position overseas and/or performs in-depth evaluation and analysis of pharmaceutical products stability data. Person will be responsible for supervision of stability staff that manages the shelf-life and accelerated stability program, including writing accurate and error free study protocols, compiling interpreting data and approving summarized data in stability reports.

    Key Activities/Responsibilities:

    Provides training to fellow associates in stability program and basic statistical principles.

    Responsible for human resources within the department, including the periodic evaluation of performance against plans and standards.

    Responsible for the GxP, ISO, and EHS procedure awareness and compliance within the respective area. Support customer and regulatory audits as needed.

    Assure departmental compliance of applicable FDA, OSHA (safety), ISO, etc. regulations and support compliance awareness through tracking and communication of key metric data.

    Coordinate, support, perform activates related to stability program, annual product review, GEO expansion, new and modified product development.

    Coordinates and Supports various production, engineering, quality, regulatory, and technical teams in the evaluation of data; looks for variation trends and helps to establish appropriate control (shelf-life and release), alert, and action limits.

    Coordinate and perform functions related to and including: creation of stability studies and stability batch records, ensuring/verifying placement of lots on stability and updating stability database, tracking of stability lots.

    Trending, analysis, and writing of technical and stability reports to support annual product review, regulatory filing for new/modified process and/or product investigations.

    Reviews and evaluates stability data. Identifies, analyses, reports and confirms out of trend or out of specifications results to the Department Management.

    Collects and analyzes pharmaceutical drug product stability data via appropriate statistical methods.

    Looks for variation trends and helps to establish appropriate control, alert, and action limits.

    Evaluate product degradation trends and confidence limits.

    Prepares written documentation, including protocols and reports, to support product shelf-life claims. Prepare, review and approve charts, graphs, or forms to go along with the reports.

    Identifies improvements for current procedures and practices and revises documentation accordingly.

    Supports and/or conduct NC investigations.

    Maintains filing system and document retention program.

    Maintenance of quality systems and cGMP compliance for the business by ensuring compliance with processes, procedures and instructions for all activities.

    QC laboratory support on as needed basis (trend report preparation). All other duties as required and assigned.

    Scope of Position:

    Position typically supports one functional area of stability department objectives with some support to internal/external customers.

    Duties are performed under the supervision of the Department Manager or designee.

    Qualifications/Training:

    Demonstrated ability to apply statistical tools and models to help solve product performance variability issues.

    Use of Statistical programming, Statistical Modeling, and Statistical Tools (i.e. ScienTek, MiniTab, and Excel) is required. Experience in Microsoft programs, inventory management systems, document control systems, and lab data systems are preferred.

    5 years working in biotech/pharmaceutical Industry experience.

    Computer software skills (Word processing, database and spreadsheets). Adequate typing skills.

    Ability to read, analyze, and interpret

    analytical data.

    Excellent verbal and written communication skills.

    Ability to make effective and persuasive presentations.

    Strong analytical and problem-solving skills.

    High degree of initiative and self-motivation. Ability to work independently.

    Demonstrated ability to identify and adapt to shifting priorities and competing demands.

    Strong attention to detail and accuracy.

    Strong time management and prioritization skills for management of multiple projects.

    Ability to work effectively independently and within teams.

    Strong organization skills.

    Organizational savvy, ability to navigate/ network within a large organization. Ability to establish and maintain effective working relationships with others.

    Diplomacy, negotiation skills, written and oral communication, independent work skills, strong work ethic.

    Knowledge of cGMP (Pharmaceutical industry) is a plus (Training will be provided).

    Experience:

    College or Bachelors degree required.

    5+ years in Pharmaceuticals or related industry.

    Expertise in statistical principles, methods, and procedures and the ability to instruct others in these areas.

    Knowledge of statistical sampling practices.

    Previous experience in application of statistical models to predict product long term stability.

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