Current jobs related to Quality Assurance Associate III - Saddle Brook, New Jersey - Lynkx Staffing LLC

  • Quality Assurance Associate III

    2 weeks ago

    Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full time

    Job DescriptionAt Lynkx Staffing LLC, we are seeking a highly skilled Quality Assurance Associate III to join our team. As a Quality Assurance Associate III, you will be responsible for performing quality assurance activities within minimal supervision of daily tasks in support of quality systems and/or client procedures. This includes document management,...

  • Quality Assurance Manager

    2 weeks ago

    Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full time

    Job SummaryLynkx Staffing LLC is seeking a highly skilled Quality Assurance Manager to join our team. The successful candidate will be responsible for managing the PPU support unit services of the QA department and ensuring compliance with corporate Quality Systems and client procedures.Key ResponsibilitiesPerform Quality Assurance activities with minimal...

  • Quality Assurance Manager

    1 month ago

    Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full time

    Job Title: Quality Assurance ManagerLynkx Staffing LLC is seeking a highly skilled Quality Assurance Manager to join our team. As a Quality Assurance Manager, you will be responsible for managing the quality assurance process, ensuring compliance with regulatory requirements, and implementing quality improvement initiatives.Key Responsibilities:Develop and...

  • Quality Assurance Manager

    7 days ago

    Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full time

    Job DescriptionAt Lynkx Staffing LLC, we are seeking a highly skilled Quality Assurance Manager to join our team. This role will be responsible for overseeing and managing Quality Assurance Validation/Qualification activity across two manufacturing sites in Allendale, NJ. The ideal candidate will have a strong background in GMP quality programs, with...

  • Quality Assurance Compliance Investigator

    3 weeks ago

    Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full time

    Job Title: Quality Assurance Compliance InvestigatorLynkx Staffing LLC is seeking a highly skilled Quality Assurance Compliance Investigator to join our team in Allendale, NJ. As a Quality Assurance Compliance Investigator, you will play a critical role in ensuring the quality and compliance of our products and services.Key Responsibilities:Conduct...

  • Quality Assurance Compliance Investigator

    6 days ago

    Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full time

    Job Title: Quality Assurance Compliance InvestigatorLynkx Staffing LLC is seeking a Quality Assurance Compliance Investigator to join our team in Allendale, NJ. As a Quality Assurance Compliance Investigator, you will be responsible for performing Quality Assurance Compliance activities in support of company and/or client procedures, including document...

  • Quality Assurance Specialist

    2 weeks ago

    Saddle Brook, New Jersey, United States Aerotek Full time

    Job SummaryWe are seeking a skilled Quality Assurance Specialist to join our team at Aerotek. As a Quality Inspector, you will be responsible for completing final inspections of air compressors, reading and interpreting blueprints, and using measuring tools to ensure accuracy.Key Responsibilities:Conduct final inspections of air compressors to ensure quality...

  • Supplier Quality Assurance Specialist

    6 days ago

    Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full time

    Job SummaryLynkx Staffing LLC is seeking a highly skilled Supplier Quality Auditor to join our team. As a key member of our quality assurance team, you will be responsible for ensuring compliance with regulatory requirements and company procedures through external auditing of suppliers.Key ResponsibilitiesDevelop and maintain a risk-based external auditing...

  • Quality Assurance Laboratory Specialist

    2 weeks ago

    Saddle Brook, New Jersey, United States JCS Family Full time

    Job SummaryThe Quality Assurance Laboratory Specialist will be responsible for preparing raw material and bulk material samples, conducting laboratory testing, tracking stability, and preparing final reports. This individual will also perform general laboratory functions and assist other quality control projects.Key Responsibilities:Initiate studies for raw...

  • Quality Assurance Investigator

    6 days ago

    Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full time

    Job Title: Quality Control Compliance InvestigatorLynkx Staffing LLC is seeking a highly skilled Quality Control Compliance Investigator to join our team in Allendale, NJ.Job Summary:The Quality Control Compliance Investigator will be responsible for leading life-cycle investigations, including deviations, environmental excursions, non-conformances,...

  • Quality Assurance Investigator

    7 days ago

    Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full time

    Job DescriptionLynkx Staffing LLC is seeking a Quality Assurance Investigator to lead life-cycle investigations, including deviations, environmental excursions, non-conformances, discrepancies, and other issues to improve processes and ensure compliance.Conduct investigations to determine causes and implement corrective and preventative actions.Drive...

  • Quality Assurance Laboratory Specialist

    4 weeks ago

    Saddle Brook, New Jersey, United States JCS Family Full time

    Job SummaryWe are seeking a highly skilled Quality Control Laboratory Technician to join our team at JCS Family. The successful candidate will be responsible for preparing raw materials and bulk samples, conducting laboratory testing, and tracking stability.Key Responsibilities:Prepare raw materials and bulk samples for testingConduct laboratory testing and...

  • Quality Assurance Laboratory Technician

    4 weeks ago

    Saddle Brook, New Jersey, United States JCS Family Full time

    Job SummaryWe are seeking a highly skilled Quality Control Lab Technician to join our team at JCS Family. The successful candidate will be responsible for preparing raw material and bulk material samples, conducting lab testing, tracking stability, and preparing final reports.Key Responsibilities:Initiate studies for raw materials and bulk materialsGather...

  • Senior Manager Quality Assurance Validation Computerization Systems

    1 month ago

    Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full time

    Job SummaryThe Senior Manager Quality Assurance Validation Computerization Systems will be responsible for supporting the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10...

  • Quality Control Compliance Investigator

    1 month ago

    Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full time

    Job OverviewLynkx Staffing LLC is seeking a highly skilled Quality Control Compliance Investigator to join our team. As a key member of our quality assurance team, you will be responsible for leading life-cycle investigations, including deviations, environmental excursions, non-conformances, discrepancies, and other quality-related issues.Key...

  • Quality Assurance Specialist

    4 weeks ago

    Saddle River, New Jersey, United States Mercury Systems Full time

    Job DescriptionMercury Systems is seeking a highly skilled Quality Inspector to join our team. As a Quality Inspector, you will play a critical role in ensuring the quality of our products meets the high standards of our customers.Key Responsibilities:Perform in-process visual verification of electronic assemblies to ensure compliance with IPC Industry...

  • Quality Control Microbiology Team Lead

    6 days ago

    Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full time

    Job Title: Quality Control Microbiology SupervisorLynkx Staffing LLC is seeking a highly skilled Quality Control Microbiology Supervisor to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality and compliance in our microbiology laboratory.Key Responsibilities:Lead and direct a...

  • Associate Director Manufacturing Operations

    4 weeks ago

    Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full time

    Job DescriptionLynkx Staffing LLC is seeking a highly skilled and experienced Associate Director, Manufacturing Operations to join our team. As a key member of our operations team, you will be responsible for ensuring the efficient utilization of operations resources to meet customer demand.Key Responsibilities:Develop and implement strategies to optimize...

  • Senior Quality Control Specialist

    6 days ago

    Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full time

    Job SummaryLynkx Staffing LLC is seeking a highly skilled Quality Control Analytical Associate II to join our team in Allendale, NJ. As a key member of our Quality Control team, you will play a critical role in ensuring the quality and safety of our products.Key ResponsibilitiesPerform analytical testing and quality control procedures to ensure compliance...

  • Quality Assurance Auditor

    2 weeks ago

    Bound Brook, New Jersey, United States Paragon Staffing, LLC Full time

    Job DescriptionParagon Staffing, LLC is a company that specializes in connecting job seekers with employers who are seeking temporary, contract, or permanent positions.As a Quality Assurance Auditor, you will be responsible for ensuring that products meet the established standards of appearance or performance.Key Responsibilities:Evaluate and provide...

Quality Assurance Associate III

2 months ago

Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full time
Job Description

Lynkx Staffing LLC is a leading staffing agency specializing in placing talented professionals in the Biotechnology, Pharmaceutical, and Medical Device industries. We are seeking a highly skilled Quality Assurance Associate III to join our team.

Key Responsibilities
  • Perform Quality Assurance activities with minimal supervision, ensuring compliance with quality systems and client procedures.
  • Manage document management, issuance, review, and approval of batch records, SOPs, Qualification and Validation Reports, and QC data.
  • Perform material releases and final product releases, and review Deviations.
  • Assist Quality management with department needs, exercising judgment within generally defined practices and policies.
  • Manage internal and external audits, including interaction with Health Authorities and clients.
  • Interface directly with clients and cross-functional teams to provide resolutions for quality-related project issues.
  • Prioritize, schedule, and manage multiple projects and resources (teams) independently.
  • Ensure the safe release of cellular products in accordance with company and/or client procedures and requirements.
  • Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs.
  • Provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues.
  • Author and review relevant SOPs, validation, and other documents.
  • Responsible for the timely issuance, review, and approval of QC certificates, closure of Batch Records, and deviation reports.
  • Responsible for the completion of all client requirements related to cellular product and/or material releases.
  • Master Batch Record Control, distribution, and label verification.
  • Perform line clearance activities as required.
  • Assignment and maintenance of product Lot numbers as applicable.
  • Perform internal documentation audits as assigned.
  • Materials management nonconformance disposition and release activity as applicable.
  • Responsible for accurate deviation reporting as applicable and tracking/trending follow-up actions to closures.
  • Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions.
  • Track and trend relevant quality metrics, including environmental monitoring data.
  • Provide Quality Assurance-related support to various departments.
  • Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies.
  • Electronic Document Control activities as assigned.
  • Provide training to personnel as assigned by supervisor.
  • Travel may be required.
Requirements
  • Bachelor's degree in biological sciences or other relevant field of study.
  • 5+ years of experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics.
  • Working knowledge and technical understanding of aseptic manufacture of biologics.
  • Understanding of quality system applications.
  • Experience in both clinical and commercial manufacturing is preferred.
  • Experience in authoring, reviewing, and/or approving cGMP/cGTP-related documents (validation/qualification reports, SOPs, etc.).
  • Experience in organizing teams for effective and timely completion of projects.
  • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc.
  • Experience participating in or hosting health authority inspections and/or client audits.
  • Computer skills (Microsoft Office, Outlook).
  • Detail-oriented and organized.
  • Analytical and problem-solving skills.
  • Good written and oral communication skills.
  • Ability to multi-task and be adaptable.
  • Flexible and able to adapt to company growth and evolving responsibilities.
  • Ability to work independently and with a team.
  • Strong Project Management and organization skills.
  • Must have the ability to work in a team-oriented environment and with clients.
  • Must be able to work during the weekend, holidays, and as required by the company.