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    Customer Quality Specialist - Rochester, United States - Unither Pharmaceuticals

    Unither Pharmaceuticals
    Unither Pharmaceuticals Rochester, United States

    2 weeks ago

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    Description
    Customer Quality Specialist
    Who we are?

    We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify patients' lives to as many people as possible.

    With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 employees.

    Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 280 employees.
    Your role
    Reporting to the Quality Assurance Manager,

    The Customer Quality Specialist conducts and supports problem investigations (deviations), change controls and customer complaints in accordance with company procedures and current regulatory requirements, for sterile and non-sterile products.

    For complaints this includes managing the receipt, processing and monitoring of each complaint and providing the completed investigation to the customer within the required timeframe.

    The Customer quality specialist completes review of laboratory data and completes final release of finished products.

    This position will serve as a frequent inter-organizational contact and will represent the QA department on teams for the Customers.

    This role is responsible for review and approve a wide variety of GMP related documents and provide appropriate feedback when necessary.

    This position interacts with manager and director levels of management in all departments in developing solutions and providing timely and accurate communication.

    As a Customer Quality Specialist, frequent interactions will occur with our customers including documentation approvals, deviations, change controls and various meetings and business reviews.

    The Customer Quality Specialist will serve as the main QA contact for customers regarding deviations, Change Controls, complaints and any other quality concerns.


    ESSENTIAL FUNCTIONS / RESPONSIBILITIES:
    Quality System Guidance & Advice (30%)

    Provides Quality Assurance consultation which may include:
    Complaints, Deviations, change controls, laboratory and operations related items and standard operating procedure changes
    Consultation must meet current regulatory requirements and be appropriate for the business.
    Provide critical support during regulatory agency and customer audits

    Receivers of guidance report:
    Guidance is practical and provided in time to be actionable.
    Interpretation of regulatory requirements is communicated in a way that is easily understood by the receiver.
    Consultation meets current regulatory requirements and is appropriate for the business.
    Safe, Effective Products (50%)
    Assist/lead and close investigations the required time period

    Ensure investigations are conducted according to the severity defined in the SOP and support the investigation team throughout the investigation.

    Propose CAPA if needed and ensure any identified CAPAs are implemented.
    Participate to the recurrences analysis to define and deploy the appropriate CAPA
    Review and release the commercial batches according to the schedule, including MFT batches needed to support sterile products.
    Lead and complete complaint investigations
    Serve as the main contact for customers including attending routine meetings.
    Review and challenge the quality agreement before approval by the quality managers

    To BOM updates, equipment recipe updates, batch cards changes, and other documents linked to your scope, required for the above changes.

    Products meet customer needs and regulatory requirements and do not result in recalls
    No recalls or audit observations associated with released product
    Effective, Efficient Quality System (20%)
    Ensures standard operating procedures and processes meet current industry requirements and are efficient for the business.
    Ensures CAPAs address root cause and reduce recurrence rates.
    Reviews and approves documentation such as procedures, protocols, reports as required by regulations.
    Ensures Change Controls are thorough and meet industry requirements.
    Provides support during customer and regulatory inspections.
    Ensures Quality Metrics are delivered.

    Supervisor's observation:
    Annual improvement is demonstrated on key process metrics
    Process improvement suggestions and/or changes do not have a negative impact on other departments
    Incumbent identifies process improvement opportunities that ensures compliance and quality and /or adds measurable value
    SOP's meet industry requirements and are determined to be effective
    No deviations resulting from users not following procedures.
    Informs management immediately of any quality-related concerns and risk to the organization.

    KNOWLEDGE SKILLS & ABILITIES:

    Attention to Detail:

    Is thorough and precise in accomplishing a task through concern for all the areas involved, no matter how small; monitors and checks work or information and plans and organizes time and resources efficiently; double-checks the accuracy of information and work product to provide accurate and consistent work; provides information on a timely basis and in a usable form to others who need to act on it; remains aware and takes care of details that are easy to overlook or dismiss as insignificant; compares observations of finished work to what is expected to find inconsistencies.


    Customer Focus:

    Is dedicated to meeting the expectations and requirements of internal and external customers; gets first-hand customer information and uses it for improvements in products and services; acts with customers in mind; establishes and maintains effective relationships with customers and gains their trust and respect.


    Decision Quality:

    Makes good decisions (without considering how much time it takes) based upon a mixture of analysis, wisdom, experience, and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions.


    Written Communication:

    Is able to write clearly and succinctly in a variety of communication settings and styles; can get messages across that have the desired effect.


    Technical Learning:

    Picks up on technical things quickly; can learn new skills and knowledge; is good at learning new industry, company, product, or technical knowledge; does well in technical courses and seminars.

    Your profile
    Bachelor's Degree in Chemistry, Biology, Pharmacy or related field.
    Minimum of 2-5 years' experience in FDA regulated environment, preferably in a pharmaceutical manufacturing setting.
    QA/compliance experience in manufacturing, facility operation, laboratory compliance and quality system.
    Experience in audits and regulatory inspections (FDA & others).
    Compensation range
    65, ,000.00 USD
    *The referenced compensation range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

    Learn more about us:


    We are a dynamic company driven by a spirit of victory and are therefore pursuing strong growth while maintaining a close relationship with our customers and employees.

    Our culture is based on 5 values: Respect, Responsibility, Trust, Courage and Innovation.

    We are committed to bringing these values to life with our employees by granting them a high degree of autonomy in the exercise of their profession and by encouraging their initiatives.

    We are committed to providing them with working conditions and atmosphere that is conducive to their development and the expression of their potential.

    We propose you to integrate a site that values the meaning of work and that entrusts our employees with a high level of responsibility.

    Join us and make a difference
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