Quality Control Analytical Compliance Investigator

1 week ago

Saddle Brook, United States Lynkx Staffing LLC Full time
Job DescriptionJob 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 Compliance Investigator to lead life-cycle investigations, including but not limited to deviations, environmental excursions, non-conformances, discrepancies, etc. to improve the processes by implementing corrective and preventative actions to ensure compliance.
  • Determine the causes and preventative actions of Deviations, Non-Conformances, OOS, OOT, field complaints and environmental excursion investigations.
  • Drive investigations to true root cause using appropriate investigation tools.
  • Benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets.
  • Define and implement effective preventative actions to prevent recurrence.
  • Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates.
  • Collaborate with cross-functional teams to develop and track CAPA plans.
  • Identify and create appropriate trending rules that trigger corrective actions.
  • Analyze process data and evaluate trends to identify major improvement opportunities.
  • Effectively utilize change management approach.
  • Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy and deviation process.
  • Champion CAPA plans and implementation.
  • Provide communication plan for on-going deviations & CAPA’s.
  • Effectively create and communicate CAPA plan to responsible parties.
  • Oversee timely completion of deviations, CAPAs, and Change Controls as necessary.
  • Ability to abide by quality standards.
REQUIREMENTS
  • BS in a Quality / Process related field.
  • Experience in GMP Operations and/or QA in Cell Therapies, Biotechnology or Bio-Pharma.
  • Root cause analysis experience in pharmaceutical or FDA regulated operation preferred.
  • Experience using e-Quality Management Systems preferred.
  • Relevant IT skills (able to work with Visio, Microsoft Project and Excel)
  • Ability to think strategically and tactically (detail-oriented)
  • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment
  • Analytical and problem-solving skills
  • Strong written and oral communication skills
  • Flexible and able to adapt to company growth and evolving responsibilities
  • Integrity, accountability and strong dedication to regulatory compliance
  • Continuous improvement mindset
  • Ability to work effectively as a team and independently.
  • GMP Trained, Quality Systems Trained (Deviation/CAPA)
Working EnvironmentWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy. Physical RequirementsThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Non-absorbent laboratory coats are required, as well as latex (or a non-latex substitute) gloves. When working with potentially hazardous materials that may spray, aerosol, or otherwise contact skin or mucous membranes, face shields or goggles must be worn. Heavy cryo-gloves must be used when working with liquid nitrogen. Other DutiesPlease 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.

  • Qualtiy Control Compliance Investigator

    3 weeks ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job DescriptionJob 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 investigations, including but not limited to deviations, environmental excursions,...

  • Quality Assurance Compliance Investigator

    3 weeks ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job DescriptionJob 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...

  • Quality Control Analytical Scientist

    2 weeks ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionQuality Control Analytical ScientistAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The QC Analytical Scientist will be a member of the Quality Control Department. As a Senior Member of the team the QC Analytical...

  • Compliance Investigator, Clinical Manufacturing

    3 weeks ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job DescriptionJob 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 Investigator, Clinical Manufacturing leads life-cycle investigations, including but not...

  • Quality Control Analytical Associate II

    1 week ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionQuality Control Analytical Associate IIAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Quality Control Analytical Associate II serves as a support role to clinical and commercial production....

  • Quality Control Manager

    10 hours ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job Description Job Description Quality Control Manager The Quality Control (QC) Manager plays a pivotal role in ensuring that QC is effectively serving in its support role to clinical and commercial production. The QC Manager will ensure that analytical testing for process check points, stability, and release assays are being carried out to certify that...

  • QC Manager, Training

    4 days ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job Description Job Description Quality Control Manager, Training & Compliance Allendale, NJ The Quality Control (QC) Manager, Training and Compliance will manage the training and compliance programs across the analytical and microbiological laboratories. This role will ensure that there is a robust training program for the analytical and microbiological...

  • QC Manager, Training

    3 weeks ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionQuality Control Manager, Training & ComplianceAllendale, NJ The Quality Control (QC) Manager, Training and Compliance will manage the training and compliance programs across the analytical and microbiological laboratories. This role will ensure that there is a robust training program for the analytical and microbiological...

  • Quality Control Manager

    1 week ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionQuality Control Manager The Quality Control (QC) Manager plays a pivotal role in ensuring that QC is effectively serving in its support role to clinical and commercial production. The QC Manager will ensure that analytical testing for process check points, stability, and release assays are being carried out to certify that...

  • Quality Control Manager

    1 week ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionQuality Assurance Manager The Manager, Quality Assurance manages the PPU support unit services of the QA department and overall expectations pertaining to setting accurate schedules and resources. The Manager, Quality Assurance is responsible for performing Quality Assurance activities with minimal if any supervision of daily...

  • Quality Assurance Compliance Specialist

    1 week ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionQuality Assurance Compliance SpecialistAllendale, 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 Compliance. Responsible to perform Quality Assurance Compliance...

  • Quality Assurance Manager

    3 weeks ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionQuality Assurance ManagerAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Manager, Quality Assurance manages the PPU support unit services of the QA department and overall expectations...

  • Quality Control Microbiology Engineer III

    3 weeks ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionQuality Control Microbiology Engineer III Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. The Quality Control Microbiology Engineer III will support two local sites. Serving as a support role to clinical...

  • Quality Assurance Associate III

    6 hours ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job Description Job Description Quality Assurance Associate III Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Quality Assurance Associate III is responsible for performing Quality Assurance activities within minimal...

  • Quality Assurance Associate III

    1 week ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionQuality Assurance Associate IIIAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Quality Assurance Associate III is responsible for performing Quality Assurance activities within minimal...

  • Sr. Technical Trainer

    1 week ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionQuality Analytical Sr. Technical TrainerAllendale, NJ The QC Senior Technical Trainer facilitates and conducts on-the-job training for QC personnel; for both the effective induction of new hires into QC, as well as, the ongoing improvement and proficiency (i.e. cross-training) of personnel within the department, by delivering...

  • QC Microbiology Analist I, II, III

    3 days ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionQuality Control Microbiology Analytics I, II, III QC Microbiology Analyst I The Quality Control Microbiology Analyst I serves as a support role to clinical and/or commercial production. The QC Microbiology Analyst I will perform environmental monitoring activities including, but not limited to, non-viable particulate testing,...

  • QC Microbiology Analist I, II, III

    1 week ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionQuality Control Microbiology Analytics I, II, III QC Microbiology Analyst I The Quality Control Microbiology Analyst I serves as a support role to clinical and/or commercial production. The QC Microbiology Analyst I will perform environmental monitoring activities including, but not limited to, non-viable particulate testing,...

  • Group Controller

    1 week ago

    Oak Brook, United States Stealth Recruiting Services Full time

    Job DescriptionJob Description150k to 200kAs our Group Controller you will be responsible for leading, directing and overseeing the accounting for multiple manufacturing sites within the business unit level. Key actions will include preparing, consolidating, and executing sites P&L, which include monthly, quarterly and annual close processes, financial...

  • QC Microbiology Analyst II, III

    3 days ago

    Saddle Brook, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionQuality Control Microbiology Analyst II, IIIAllendale, NJ QC Microbiology Analyst II The Quality Control Microbiology Analyst II serves as a support role to clinical and commercial production. Microbiology Analyst II will perform environmental monitoring activities including, but not limited to, non-viable particulate testing,...