Talent.com
QA Lead

QA Lead

Quanta part of QCS StaffingNorth Carolina
30+ days ago
Job type
  • Temporary
Job description

QA Lead - Biotechnology - North Carolina - 6-Month Contract

Our client is a leader in helping address some of the world’s biggest science, health, and environmental challenges. The company work together to accelerate research, solve complex analytical challenges, improve patient diagnostics, drive laboratory productivity and produce life-saving treatments for patients.

Responsibilities :

  • Generate and maintain the contamination control strategy.
  • Promote understanding of and compliance with SA related regulations such as EU Annex 1 & the FDA’s aseptic processing guide.
  • Conduct regular GEMBA style assessments of the aseptic process on site to assess compliance, identify improvements and provide real time coaching to aseptic staff.
  • Define, oversee and where necessary improve the EM & APS programs.
  • Ensure that suitable aseptic comportment / training / oversight programs are in place and effective. The programs should cover aseptic operators and the first line managers / quality staff charged with overseeing aseptic manufacturing and must be appropriate to the SA related tasks each person conducts.
  • Ensure that all sterilization processes are being managed compliantly.
  • Conduct risk assessments and improvement programs to ensure that SA practices stay aligned with current and future regulatory expectations.
  • Lead major investigations into issues impacting SA (i.e. Adverse EM trends, media fill failures)
  • Review & approve any major / critical deviation and any change proposals with SA impact.
  • Stay up to date with best practice and actively share that knowledge.
  • Act as SA SME for the above with regulators / clients (i.e. key part of major audits)
  • Act as SA SME for new product introduction and for applicable capital projects (i.e. new lines / processes)

Requirements :

  • Substantial experience, minimum 7-10 years’ working in or directly supporting manufacturing within a sterile pharmaceutical manufacturing site. This position requires deep understanding of sterile product manufacture and good aseptic practices. This knowledge needs to be combined with quality risk management principles.
  • Strong working knowledge of the principles and guidelines for GMP as set out in the Eudralex Volume 4, U.S. 21CFR part / and able to operate as a subject matter expert on regulations pertaining to aseptic manufacturing such as EU Annex 1 and the FDA aseptic processing guide.
  • Is not afraid to make decisions. Holds self and others accountable in achieving goals.
  • Strong leadership skills with good collaboration, communication, and problem-solving skills.
  • Excellent written and verbal communication skills to internal and external stakeholders
  • Wants to learn and have a natural curiosity to understand systems and processes.
  • Ability to work in a fast paced, matrix environment essential.
  • Capable of working to deadlines and prioritizing multiple tasks.
  • If this role is of interest to you, please apply now!

    North Carolina

    Create a job alert for this search

    Qa Lead • North Carolina

    Related jobs
    SAP PP- QM

    SAP PP- QM

    Eagle Eye TechnologiesNC, United States
    Full-time
    Quick Apply
    Title : SAP PP / QM Consultant Location : Raleigh, NC &...Show moreLast updated: 6 days ago
    • Promoted
    Director, QA Drug Substance Operations

    Director, QA Drug Substance Operations

    FUJIFILMHolly Springs, NC, US
    Full-time
    Director, QA Drug Substance Operations.Are you a strategic leader with expertise in managing teams of QA professionals and collaborating seamlessly with manufacturing and support functions? If you ...Show moreLast updated: 30+ days ago
    SoftPro SaaS Team Direct Hire

    SoftPro SaaS Team Direct Hire

    QED NationalUSA, North Carolina, Raleigh
    Full-time +1
    Senior Software Engineer - Technical Lead.The SaaS Development Team is seeking a.Senior Full-Stack Software Engineer.This role will also be responsible for maintaining and enhancing existing compon...Show moreLast updated: 30+ days ago
    Quality Assurance Lead 1.19

    Quality Assurance Lead 1.19

    Focused HR SolutionsRaleigh, North Carolina, United States
    Full-time
    Quick Apply
    M-2 650718 - IT Quality Assurance Lead - Raleigh, NC.Candidates will be allowed to work remotely during COVID.Once restrictions are lifted and the client’s office opens, candidates will be re...Show moreLast updated: 30+ days ago
    Sr.Technical Lead

    Sr.Technical Lead

    Shrive Technologies LLCNC, United States
    Full-time
    Quick Apply
    Strong hands-on experience with Fuji Synapse EIS, RIS, PACS, and VNA.In-depth knowledge of DICOM, HL7, and radiology imaging workflows. Familiarity with PowerScribe360, Rad AI, Intelerad PACS, and i...Show moreLast updated: 6 days ago
    QA Manager, Quality Risk Management - Now Hiring!

    QA Manager, Quality Risk Management - Now Hiring!

    AstellasSanford, NC, United States
    Full-time
    QA Manager, Quality Risk Management.Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative a...Show moreLast updated: 30+ days ago
    • Promoted
    QA Specialist, LMS

    QA Specialist, LMS

    FUJIFILMHolly Springs, NC, US
    Full-time
    The QA Specialist, LMS is responsible for collaborating alongside current team members with the creation of curriculum, serving as ComplianceWire administrator, assisting in the continual developme...Show moreLast updated: 30+ days ago
    • Promoted
    QA Manager, Analytical Services - Combo Products

    QA Manager, Analytical Services - Combo Products

    Iviva MedicalDurham, NC, US
    Full-time
    Quality Assurance Manager, Analytical Services.We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to p...Show moreLast updated: 19 days ago
    Lead Healthcare Solutions Architect (RapidScale)

    Lead Healthcare Solutions Architect (RapidScale)

    MediabistroRaleigh, NC, United States
    Full-time
    At RapidScale, exceptional technology is powered by exceptional people.We deliver secure, reliable managed and advisory services across private, public, and hybrid clouds, helping organizations inn...Show moreLast updated: 30+ days ago
    • Promoted
    QA Manager, Quality Risk Management

    QA Manager, Quality Risk Management

    Astellas PharmaSanford, NC, US
    Full-time
    QA Manager, Quality Risk Management.Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative a...Show moreLast updated: 30+ days ago
    QA Manager, Quality Risk Management - Urgently Hiring!

    QA Manager, Quality Risk Management - Urgently Hiring!

    AstellasSanford, NC, United States
    Full-time
    QA Manager, Quality Risk Management.Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative a...Show moreLast updated: 30+ days ago
    C&Q Specialist

    C&Q Specialist

    Mentor Technical GroupNC, US
    Full-time
    Quick Apply
    Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutio...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Director QA for Materials, Supply Chain and QC

    Associate Director QA for Materials, Supply Chain and QC

    FUJIFILMHolly Springs, NC, US
    Full-time
    The Associate Director, QA for Materials, Supply Chain and QC will be responsible for the supervision of the Quality teams supporting release of materials, Supply Chain functions including warehous...Show moreLast updated: 30+ days ago
    QA Manager, Quality Risk Management

    QA Manager, Quality Risk Management

    AstellasSanford, NC, United States
    Full-time
    QA Manager, Quality Risk Management.Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative a...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Specialist Quality Assurance - Level III (Senior) Senior Specialist Quality Assurance - Level III (Senior)

    Senior Specialist Quality Assurance - Level III (Senior) Senior Specialist Quality Assurance - Level III (Senior)

    StaffingDurham, NC, US
    Full-time
    Join A Global Leader In Workforce Solutions Net2source Inc.Recognized for 300% growth in the past three years, we operate in 34 countries with a global team of 5,500+. Our mission? To bridge the ta...Show moreLast updated: 11 days ago
    SAP Test Lead

    SAP Test Lead

    Shrive Technologies LLCRaleigh, NC, United States
    Full-time
    Quick Apply
    JobDetail" style="width : 92%; border-collapse : collapse; border-spacing : 0px; box-sizing : border-box"> ...Show moreLast updated: 3 days ago
    QA Systems Specialist - eQMS & CSV Projects

    QA Systems Specialist - eQMS & CSV Projects

    MedPharmDurham, NC, US
    Full-time
    Quick Apply
    Position Summary QA Systems Specialist – eQMS & CSV Projects will be leading and supporting the implementation, migration, validation, and ongoing management of key electronic Quality Man...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Director, QA Engineering - Combo Products

    Associate Director, QA Engineering - Combo Products

    Iviva MedicalDurham, NC, US
    Full-time
    Associate Director, Qa Engineering.We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a bri...Show moreLast updated: 16 days ago
    • Promoted
    QA MANAGER

    QA MANAGER

    On BoardCreedmoor, NC, US
    Full-time
    The QA Manager is responsible for helping to execute and improve the Quality Management System to requirements.The QA Manager heavily participates in the company's production activities, ensuring t...Show moreLast updated: 18 days ago
    • Promoted
    UAT Test Lead (Consulting)

    UAT Test Lead (Consulting)

    Edwards Lifesciences BelgiumRaleigh, NC, United States
    Full-time
    SolomonEdwardsGroup, LLC (SolomonEdwards) is a full-service professional services firm offering financial, operational, and technology consulting and operations support. We work with some of the wor...Show moreLast updated: 1 day ago