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    QC Analyst III - Cumberland, United States - NEUROTECH U S A

    NEUROTECH U S A
    NEUROTECH U S A Cumberland, United States

    2 weeks ago

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    Description

    Job Description

    Job Description

    Neurotech Pharmaceuticals is an innovative biopharmaceutical company located in Cumberland, RI, within the realm of Greater Boston's vast biotechnology landscape. Since our inception more than 20 years ago, we have been developing a proprietary biological drug device combination technology for treatment of a variety of retinal disorders. Our most advanced program is developing a treatment for the orphan disease Macular Telangiectasia Type 2 (MacTel). Our Encapsulated Cell Technology (ECT) platform is designed to deliver a genetically modified neuroprotective factor to slow the progression of this chronic retinal disease.

    We are currently seeking a QC Bioanalytical Analyst to add to our growing organization. This hire will provide support for raw material and bioanalytical lot release and stability testing, while also refining our QC processes as we prepare for commercial launch. These laboratory operational cGMP processes include raw material testing, in-process testing, final product specification testing, stability indicating testing, process validation, method transfer, method validations and results trends.

    This is an on-site role in Cumberland, RI. This is not a hybrid or remote opportunity.

    Also, please note this role is not eligible for agency recruiting support.

    Essential Functions & Duties

    • Diverse assay experience, including ELISA, DNA, Western Blot endotoxin, sterility, bioburden, environmental monitoring, and proprietary product-specific QC assay technologies.
    • Ability to monitor, collect, report and troubleshoot laboratory results, supporting investigations to the root-cause level.
    • Maintain GMP compliance, including data integrity, in order to provide dependable documentation consistency and critical assessments of product quality.
    • Support data reviews of test methods.
    • Draft and revise documents including SOPs, protocols and summary technical reports, such as laboratory investigations, deviations, CAPAs and Change Controls.
    • Identify, recommend and implement method improvements, QC workflow efficiencies and lead team continuous improvement initiatives.
    • Experience supporting Biological License Application (BLA) filing activities, Inspection Readiness and Commercialization.
    • Use of LIMS and Trackwise is a plus.

    Education & Experience

    • BS degree or higher in a related science (biology, molecular biology or cellular biology, chemistry or biochemistry) or equivalent combination of education and experience:
    • Minimum of 7 years of Quality Control laboratory experience within the cGMP biopharmaceuticals or pharmaceuticals industry.
    • Biologic or Drug Device Companion Product QC Operations Release Testing or Stability Indicating Method Testing experience is a plus.
    • Phase III Clinical Development to Commercial QC is a plus

    Knowledge, Skills & Abilities

    • Well organized, detail-oriented and able to effectively prioritize and accomplish work
    • Embrace "right the first time" principles and ability to work both independently and cross-functionally
    • Strong project management skills with the ability to be influential and "wear multiple hats" in a small organization to accomplish quality objectives
    • Knowledge of GMPs, understanding of FDA / ICH / USP / EP regulations and compendia; good background in Quality Control Lab Systems
    • Experience and comfort with regulatory inspectors during lab inspections is a plus
    • Excellent communication and writing skills, strong business acumen, 6σ knowledge and Kepner-Tregoe PSDM a plus
    • Effective communication and interpersonal skills within all levels of the organization

    In addition to a talented and passionate team of colleagues and unparalleled science and technology, Neurotech offers competitive compensation, benefits through Blue Cross BlueShield and HealthEquity (FSA, HSA & HRA), a 401(k) through Fidelity with a company-sponsored match, generous vacation time and company holidays. We even cover the cost of 75% of your annual medical plan deductible And that's just the beginning.

    Do you share our vision?

    Applications are currently being accepted through the Neurotech Career Center.

    Neurotech Pharmaceuticals provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

    Additionally, Neurotech does not accept unsolicited résumés or candidate profiles. If a candidate submitted in this manner is hired, no placement fee will be paid.

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