Laboratory Quality Assurance Specialist

3 weeks ago

Durham, North Carolina, United States DivIHN Integration Full time
Job Description

Job Title: Laboratory Quality Coordinator

Location: Research Triangle Park, NC

Duration: 12 Months (with Possible extension)

Job Type: Full-time

About Us: DivIHN is a CMMI ML3-certified Technology and Talent solutions firm.

Job Summary: We are seeking a highly skilled Laboratory Quality Coordinator to join our team. The successful candidate will be responsible for assisting in the management of our Quality Management System (QMS) and will strongly support our Culture of Quality.

Key Responsibilities:

  • Manage assigned day-to-day QA responsibilities in support of Quality Control and Analytical Development department activities.
  • Collaborate successfully with the Analytical Development and the Quality Control departments to ensure that direct and supportive tasks are completed within project timelines.
  • Provide quality unit review and approval of documentation including raw data, test methods, protocols and executed method qualification/transfer/verification/validation reports and stability protocols in compliance with internal and regulatory requirements.
  • Partner with Analytical Development and Quality Control department personnel to ensure successful internal and external transfer of analytical methods in support of GMP manufacturing campaigns.
  • Participate in project meetings as a Quality Unit representative and support colleagues by acting as a technical resource for quality and compliance related issues.
  • Perform daily customer-facing activities, as assigned by area management.
  • Maintain health of customer-facing activities such as document archival activities and notebook/logbook assignment and management.
  • Identify and collaborate with colleagues to implement continuous improvement initiatives.
  • Provide Quality Unit oversight of Analytical Method Development in an R&D and GLP/GMP setting.
  • Support the department Change Control, Document Management, and Deviation Management Systems.
  • Liaise with applicable department investigation writers to ensure their complete and timely resolution.
  • Review and Approve said document types as assigned.
  • Continually evaluate systems and procedures for improvement for efficiency and compliance to applicable regulatory requirements and standards.
  • Assist in the qualification and oversight of vendors, contract manufacturers, contract laboratories, and service providers.
  • Support regulatory (FDA, EMA) and internal audits/inspections per Client procedures and applicable regulatory requirements.
  • Communicate project status to stakeholders and escalate issues in a timely manner.

Requirements:

  • Strong understanding of GMP guidelines and Quality Systems with the ability to apply GMPs in conformance to U.S. standards, and where appropriate, other regulatory authority standards.
  • Ability to author, review, and interpret Standard Operating Procedures (SOPs).
  • Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible, and constructive manner.
  • Strong attention to detail, highly organized and the ability to multitask in a fast-paced, highly interactive environment.
  • Excellent verbal and written communication skills, and the ability to effectively collaborate with peers including scientific/technical colleagues.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
  • Validation activity, review of SOPS, method validations, therapeutic methods, PCR, ELISA, HPLC.
  • Early phase clinical activity, life cycle activity, method qualification and validation review reports, preview and approval of protocol and reports, review of sops, working side by side in the QC lab.
  • Methods- PCR, ELISA, (all of them are not mandatory atleast 1 or 2 should be there).
  • They must know ICH guidelines and validation methods.
  • In the analytical side, understanding of qPCR.
  • Education:
    • For Quality- BS in science, anything Higher is also fine.
    • For validation BS in engineering or life sciences.
  • Experience required:
    • Experience in any area in pharma, GMP Lab, GLP experience, not in research development, QA, equipment qualification, or computer system validation, change control exp.
    • Very strong Lab exp is overqualified.
    • LIMS exp, documents management system.
    • 5 years of experience in pharmaceutical, biotech, or biologics GMP regulated manufacturing environment with 3 years in Quality and/or Manufacturing.
    • Experience in compliance requirements related to method development and validation of the following method types: Nucleic acid analytical methods (DNA/RNA extraction, qPCR, ddPCT, RT-PCR, etc), Cell Based Assays, ELISA, Microbial testing assays (Mycoplasma and Sterility), H/UPLC, and Capillary Electrophoresis.

About Us: DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.

  • Quality Assurance Specialist

    4 weeks ago

    Durham, North Carolina, United States MILLENNIUMSOFT Full time

    Job SummaryThis position will support the Quality Assurance Unit of Corporate Preclinical Development and Toxicology in the conduct of nonclinical laboratory investigations of medical devices and materials in accordance with GLP regulations and the client CPDT Quality System.The Quality Systems Specialist II will be responsible for the development,...

  • Laboratory Quality Assurance Specialist

    3 weeks ago

    Durham, North Carolina, United States DivIHN Integration Inc Full time

    Job DescriptionAt DivIHN Integration Inc, we are seeking a highly skilled Laboratory Quality Assurance Specialist to join our team. The successful candidate will be responsible for assisting in the management of our Quality Management System (QMS) and ensuring corporate compliance with applicable GMP national, international, and state regulations.Key...

  • Quality Assurance Laboratory Associate

    4 weeks ago

    Durham, North Carolina, United States LeadStack Inc. Full time

    Job Title: QA/QC SpecialistLocation: Research Triangle Park, NC – 27709Duration: 12 Months ContractPayrate: $40/hr - $47/hr on W2Job Description:The Laboratory Quality Contractor, GMP Quality Assurance, reporting to the Manager, GMP Quality Assurance, or designee, will be responsible for assisting in the management of Quality Management System (QMS) and...

  • Quality Assurance Specialist

    3 weeks ago

    Durham, North Carolina, United States GlaxoSmithKline Full time

    Job Summary We are seeking a highly skilled Quality Assurance Specialist to join our team at GlaxoSmithKline. As a Quality Assurance Specialist, you will be responsible for providing quality oversight to support the implementation and maintenance of strategic computerized systems. You will ensure that these systems are validated and operated in accordance...

  • Senior Quality Assurance Specialist for Supplier Management

    3 weeks ago

    Durham, North Carolina, United States Tempus Full time

    We are seeking a highly skilled Senior Supplier Quality Assurance Specialist to join our team at Tempus. As a key member of our quality team, you will play a critical role in supporting quality activities related to Supplier Quality Management (SQM) in accordance with the FDA Quality System Regulation, ISO 13485, and other medical device/IVDR...

  • Quality Assurance Specialist

    3 weeks ago

    Durham, North Carolina, United States Stellar Consulting Solutions, LLC Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Stellar Consulting Solutions, LLC. As a Quality Assurance Specialist, you will be responsible for ensuring suppliers are compliant with our standards and applicable US & global regulatory requirements.Key ResponsibilitiesLead supplier & process qualificationsLead...

  • Quality Assurance Specialist

    4 weeks ago

    Durham, North Carolina, United States ICONMA Full time

    Job SummaryWe are seeking a highly detail-oriented Quality Assurance Specialist to join our team at ICONMA. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products by performing in-process and final inspections, accepting or rejecting products based on inspection criteria, and reporting any issues to our...

  • Environmental Quality Assurance Specialist

    4 weeks ago

    Durham, North Carolina, United States Piper Companies Full time

    Piper Companies is seeking a highly skilled Environmental Monitoring Specialist to ensure compliance with regulatory requirements and maintain high standards in their biopharmaceutical facility in Durham, North Carolina. The ideal candidate will have a Bachelor of Science in Biology, Microbiology, or a related field, and experience working in a clean room...

  • Quality Assurance Specialist

    3 weeks ago

    Durham, North Carolina, United States Beacon Engineering Resources Full time

    Job Summary:At Beacon Engineering Resources, we are seeking a highly skilled Quality Assurance Specialist to join our team. The ideal candidate will have a strong background in quality control and assurance, with experience in developing and implementing quality control processes and procedures.Responsibilities:Develop and implement quality control processes...

  • Quality Assurance Specialist

    4 weeks ago

    Durham, North Carolina, United States Carolina Components Group Full time

    Job OverviewThe Quality Assurance Specialist is responsible for ensuring compliance to customer specifications, ISO 9001, cGMP, and company standards. This role involves understanding and effectively operating selected aspects of the quality management program.Key ResponsibilitiesAccurately process assigned Orders through the Quality Department prior to...

  • Quality Assurance Specialist

    4 weeks ago

    Durham, North Carolina, United States The Upper Deck Company Full time

    Job SummaryWe are seeking a detail-oriented Quality Assurance Specialist to join our team at The Upper Deck Company. In this role, you will be responsible for maintaining the quality of our products and services, working efficiently in a fast-paced environment, and collaborating with internal teams to ensure seamless operations.Key ResponsibilitiesOrganize...

  • Medical Laboratory Specialist

    4 weeks ago

    Durham, North Carolina, United States Duke Health Full time

    Medical Laboratory SpecialistDuke Health is seeking a Medical Laboratory Specialist to join our team. As a Medical Laboratory Specialist, you will be responsible for performing a variety of routine and complex technical tasks in the performance of laboratory tests to obtain data for use in the diagnosis and treatment of disease.Duties and...

  • Quality Assurance Specialist

    3 weeks ago

    Durham, North Carolina, United States LanceSoft Full time

    Job DescriptionJob Title: Quality Assurance SpecialistLocation: Durham, NCDuration: 12 MonthsWork Schedule: Monday - Friday, 8am - 5pmDescription:This role supports the Supplier Quality organization in developing and managing quality assurance processes for the Durham, NC facility. The primary responsibility includes ensuring suppliers comply with client...

  • Senior Quality Assurance Specialist

    4 weeks ago

    Durham, North Carolina, United States Biogen Idec Full time

    Job SummaryWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Biogen. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality and compliance of our products and processes.The ideal candidate will have a strong background in quality assurance, regulatory compliance, and...

  • Quality Assurance Specialist

    3 weeks ago

    Durham, North Carolina, United States DivIHN Integration Inc Full time

    At DivIHN Integration Inc, we are seeking a skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products by performing in-process and final inspections using various gauges, tools, and inspection techniques.Key Responsibilities:Accept or reject products according to...

  • Quality Assurance Auditor

    4 weeks ago

    Durham, North Carolina, United States RTI International Full time

    Job SummaryWe are seeking a Quality Assurance Auditor to provide oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines.Key ResponsibilitiesProvide expertise and guidance...

  • Senior Supplier Quality Assurance Specialist

    4 weeks ago

    Durham, North Carolina, United States Tempus Full time

    Job SummaryWe are seeking a Senior Supplier Quality Assurance Specialist to join our team at Tempus. This individual will play a critical role in supporting quality activities related to Supplier Quality Management (SQM) in accordance with the FDA Quality System Regulation, ISO 13485, and other medical device/IVDR regulations.Key ResponsibilitiesSupport the...

  • Senior Quality Assurance Specialist

    3 weeks ago

    Durham, North Carolina, United States KBI BioPharma Full time

    Job SummaryThis Quality Assurance Specialist position collaborates with cross-functional teams to ensure completion of Root Cause Analysis, CAPAs, and Effectiveness Checks for Deviations according to cGMP requirements and company SOP.Reviews and approves Deviations, CAPAs, and ECs, providing support for timely review of events for classification, initiation...

  • Medical Laboratory Specialist

    3 weeks ago

    Durham, North Carolina, United States Duke University Full time

    At Duke University, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, you'll have the opportunity to advance health together.About Duke University Health System Clinical Laboratories Pursue your passion for caring and innovation as a team...

  • Quality Assurance Specialist

    1 month ago

    Durham, North Carolina, United States AISIN North Carolina Corporation Full time

    Job Title: Quality EngineerWe are seeking a highly skilled Quality Engineer to join our Plant Quality Team at AISIN North Carolina Corporation. As a Quality Engineer, you will be responsible for providing statistical information and accurate reporting to promote quality improvement. Your passion for quality assurance and troubleshooting skills will be...