Jobs
>
Saddle Brook

    Quality Assurance Compliance Investigator - Saddle Brook, United States - Lynkx Staffing LLC

    Lynkx Staffing LLC
    Lynkx Staffing LLC Saddle Brook, United States

    2 weeks ago

    Default job background
    Description

    Job Description

    Job DescriptionQuality Assurance Compliance InvestigatorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. This position will report into the (Associate) Manager of Quality Assurance (Floor support). Responsible to perform Quality Assurance Compliance activities in support of company and/or client procedures, including but not limited to, document. management: investigations, CAPA, SOPs, qualification and validation reports, QC data. Supports Quality management with various department, organizational and operational excellence initiatives. Generally, exercises independent judgment, within generally defined practices and policies, when selecting methods and techniques for obtaining solutions. This role supports internal and external audits which may include interaction with Health Authorities and clients.
    • Liaises with relevant functional groups (Operations, Facilitates, QC, EH&S) to conduct investigation and CAPA processes.
    • Conduct investigation and identify true root cause using appropriate tools.
    • Manage multiple investigations in different stages of the process to meet compliance deadlines and product release dates.
    • Reviews and approves investigations and CAPAs when required;
    • Collaborate with cross functional department to develop and track CAPA plans.
    • Prepares and issues change control as necessary.
    • Adherences and champions to all compliance regulations as required by regulatory agencies and per the Company's processes and procedures.
    • Ensures appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations.
    • Conducts trend analysis of compliance related metrics such as deviations and CAPAs.
    • Performs supplemental investigations and/or participates in project teams or assignment as necessary.
    • Support in agency, internal and/or client audits.
    • Other duties as assigned.
    REQUIREMENTS
    • B.S in biological sciences or other relevant field of study.
    • Minimum 5 years' experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred.
    • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (Investigation report, CAPA report, SOPs etc.) required.
    • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc.
    • Familiar with FDA, ISO, and other regulatory agency guidelines.
    • Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required.
    • Working knowledge and technical understanding of aseptic manufacture of biologics preferred.
    • Experience in both clinical and commercial manufacturing is preferred.
    • Experience in supporting health authority inspections and/or client audits preferred.
    • Competencies/Candidate Profile
    • Relevant 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 be able adaptable, collaborative, accountable, and have a "can-do" pioneering spirit.
    • Must be able to work in a team-oriented environment.
    • Must be able to work occasional weekends, nights, and/or holidays as required/necessary.
    • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids.
    • Must be able to handle the standard moderate noise of the manufacturing facility.
    • Must be able to work in open floor plan environment and may work in close proximity to others.
    • Wheel-o-Vator available for use.
    Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
  • Stellar Enterprises

    Compliance Investigator

    1 week ago

    Stellar Enterprises Bellerose, NY, United States Freelance

    **Join us in Bellerose, NY and be a part of shaping the future.** · At Siemens, we are dedicated to developing intelligent networks that provide our cities with light and heat. We are also experts in automation and digitalization for the process and manufacturing industries. To c ...

  • NYC Careers

    Investigations and Compliance Officer

    2 weeks ago

    NYC Careers New York, United States

    **Investigations and Compliance Officer**: · - Apply**Investigations and Compliance Officer**: · - Agency: DEPT OF CITYWIDE ADMIN SVCS · - Posted on: 05/16/2024- Job type: Full-time · Location · NYC-ALL BOROS · - Title Classification: No exam required · Department · Citywide Equi ...

  • Lynkx Staffing LLC

    Compliance Investigator, Clinical Manufacturing

    2 weeks ago

    Lynkx Staffing LLC Saddle Brook, United States

    Job Description · Job DescriptionCompliance Investigator, Clinical ManufacturingAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Compliance Investig ...

  • Lynkx Staffing LLC

    Qualtiy Control Compliance Investigator

    2 weeks ago

    Lynkx Staffing LLC Saddle Brook, United States

    Job Description · Job DescriptionQC Microbiology Compliance InvestigatorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. Leads life-cycle investi ...

  • Lynkx Staffing LLC

    Quality Control Analytical Compliance Investigator

    2 weeks ago

    Lynkx Staffing LLC Saddle Brook, United States

    Job Description · Job DescriptionQC Analytical Compliance Investigator Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. Our client is seeking a QC Analytical Complian ...

  • Lynkx Staffing LLC

    Quality Assurance Compliance Investigator

    2 weeks ago

    Lynkx Staffing LLC Saddle Brook, United States

    Job Description · Job Description · Quality Assurance Compliance Investigator Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. This position will report into the (As ...

  • Amex

    Manager-compliance: Special Investigations

    1 week ago

    Amex New York, United States

    **You Lead the Way. We've Got Your Back.** · With the right backing, people and businesses have the power to progress in incredible ways. When you join Team Amex, you become part of a global and diverse community of colleagues with an unwavering commitment to back our customers, ...

  • Lynkx Staffing LLC

    Quality Control Analytical Compliance Investigator

    2 weeks ago

    Lynkx Staffing LLC Saddle Brook, United States

    Job Description · Job Description · QC Analytical Compliance Investigator · Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. Our client is seeking a QC Analytical ...

  • Trinity Consultants

    Compliance/Deviation Investigator

    2 weeks ago

    Trinity Consultants New York, United States

    REMOTE · ADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Head-quartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involv ...

  • Memorial Sloan Kettering Cancer Center

    Compliance Investigator

    2 weeks ago

    Memorial Sloan Kettering Cancer Center New York, NY, United States Full time

    Our specialized care teams provide personalized, compassionate, expert care to patients of all ages. Informed by basic research done at our Sloan Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a rev ...

  • Minaris Regenerative Medicine

    QC Microbiology Compliance Investigator

    1 day ago

    Minaris Regenerative Medicine Allendale, United States

    Job Description · Job DescriptionQC Microbiology Compliance Investigator · At Minaris Regenerative Medicine our vision is creating future cell therapy miracles together. We are a leading global contract development and manufacturing organization dedicated to the advancement of ce ...

  • The Ladders

    AML Compliance Investigator

    2 days ago

    The Ladders New York, United States

    Company Description · Job Mobz is part of a family of incredible brands alongside Flawless Recruit and Together, we provide talent acquisition services to fit the unique hiring challenges of our clients. Whether they need help building recruiting processes, attracting top talen ...

  • City of New York

    Investigations and Compliance Officer

    2 days ago

    City of New York New York, United States

    Company Description · Job Description · DCAS's mission is to make city government work for all New Yorkers. From managing New York City's most iconic courthouses and municipal buildings, to purchasing over $1 billion annually in goods and services for more than 80 City agencies ...

  • Adyen

    AML Compliance Investigator

    2 weeks ago

    Adyen New York, United States

    This is Adyen · Adyen provides payments, data, and financial products in a single solution for customers like Meta, Uber, H&M, and Microsoft - making us the financial technology platform of choice. At Adyen, everything we do is engineered for ambition. · For our teams, we creat ...

  • Job MobZ

    AML Compliance Investigator

    2 days ago

    Job MobZ New York, United States

    Job Description · Job DescriptionCompany Description · Job Mobz is part of a family of incredible brands alongside Flawless Recruit and Together, we provide talent acquisition services to fit the unique hiring challenges of our clients. Whether they need help building recruiting ...

  • City of New York

    Investigations and Compliance Officer

    2 weeks ago

    City of New York The Bronx, United States Full time

    DCAS's mission is to make city government work for all New Yorkers. From managing New York City's most iconic courthouses and municipal buildings, to purchasing over $1 billion annually in goods and services for more than 80 City agencies what we do ensures that all agencies can ...

  • City of New York

    Investigations and Compliance Officer

    2 weeks ago

    City of New York New York, United States

    Job Description · DCAS's mission is to make city government work for all New Yorkers. From managing New York Citys most iconic courthouses and municipal buildings, to purchasing over $1 billion annually in goods and services for more than 80 City agencies what we do ensures that ...

  • Adyen

    AML Compliance Investigator

    1 week ago

    Adyen New York, United States

    Adyen provides payments, data, and financial products in a single solution for customers like Meta, Uber, H&M, and Microsoft - making us the financial technology platform of choice. At Adyen, everything we do is engineered for ambition. · For our teams, we create an environment w ...

  • Goldman Sachs

    Compliance, Compliance Testing Group, Compliance Investigator, Vice President

    2 weeks ago

    Goldman Sachs New York, United States

    Global Compliance · Our division prevents, detects and mitigates compliance, regulatory and reputational risk across the firm and helps to strengthen the firm's culture of compliance. Compliance accomplishes these through the firm's enterprise-wide compliance risk management prog ...

  • Goldman Sachs

    Compliance, Compliance Testing Group, Compliance Investigator, Vice President

    3 weeks ago

    Goldman Sachs New York, NY, United States Full time

    Global Compliance · Our division prevents, detects and mitigates compliance, regulatory and reputational risk across the firm and helps to strengthen the firm's culture of compliance · Compliance accomplishes these through the firm's enterprise-wide compliance risk management pr ...