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    Quality Control Analyst - Melville, United States - Synectics

    Synectics
    Synectics Melville, United States

    3 weeks ago

    Default job background
    Description

    The QC Stability Analyst is responsible for assisting with the company's stability program for commercial and post-approval change batches monitored on the stability program and supporting the QC Laboratories with sample receipt/control and glassware maintenance.

    For the stability department, this includes the performance of area responsibilities necessary to ensure that stability activities are in accordance to SOPs, cGMPs and FDA requirements and are consistent with objectives.

    Receive and store all stability samples in temperature-controlled environment(s) in accordance with SOP and protocol requirements.
    Coordinate sample pulls from protocol requirements, pull samples and submits to Quality Control Laboratory.
    Prepare sample labels and aliquot stability samples.
    Maintain the stability room in an organized manner and in compliance with cGMPs.
    Set up stability studies and enter results into the stability system.
    Maintain stability files in an organized manner for review.

    Adhere to all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, HS&E, and USP/NF etc.).

    Ensure all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory standards, and Departmental, Plant, and Corporate quality and Safety goals.

    Conducts self in a manner consistent with company values and supports Quality Culture initiatives.
    For the QC Laboratories, assist with Lab Technician responsibilities.
    Maintain established inventory list of chemicals and other laboratory items.
    Receives newly purchased items and distributes to analysts.
    Restock as required.

    Collection of used glassware from designated laboratory locations, cleaning of glassware using a dishwasher or by hand when necessary, restocking of clean glassware in specified areas.

    Checks receipt of laboratory samples for accuracy, documents receipt of samples in the appropriate logbook and returns sample submission sheets to initiating department, manual entry into the logbook and LIMS entry.

    This position may require the labeling, packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility; if so, this employee would be trained under OSHA's HAZWOPER standard, 29 CFR as an 8-Hour first responder, 24-Hour incident commander, or a 40-Hour incident commander.

    In lieu of HAZWOPER training, the employee will receive training on the requirements of the Resource Conservation and Recovery Act under 40 CFR

    All employees that have received the above-mentioned training upon hire will receive annual refresher training that covers the OSHA HAZWOPER standard and the requirements of RCRA.


    Qualifications

    Associate's OR Bachelor's Degree or equivalent experience
    Pharmaceutical manufacturing and/or Quality Assurance monitoring experience is highly preferred
    Knowledge of cGMPs and the ability to follow SOPs.
    Good English written and oral communication skills required
    Strong organizational skills/attention to detail required
    Basic mathematical skills required
    Working knowledge of Microsoft Word, and Excel; Proficiency with computer applications
    Ability to multi-task and adapt to changing priorities
    Ability to work in a team-oriented environment as well as being able to work independently

    Benefits


    Healthcare Insurance:
    Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois.

    Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

    Premiums are subsidized by Synectics.


    Dental Insurance:
    Synectics offers eligible employees and their dependents a dental plan through MetLife.

    Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.



    Vision Insurance:
    Synectics offers eligible employees vision insurance through VSP.

    Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

    401(k)

    Plan:
    The Synectics Inc. Investment Savings Retirement Plan.

    Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins.

    Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.


    Technical Certification Bonus:
    Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification.

    In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us.

    Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus.

    It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.


    Synectics is an equal opportunity employer.
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