Quality Assurance Investigator

3 weeks ago

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

Lynkx 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 investigations to true root cause using appropriate tools.
  • Benchmark industry standards to develop and implement investigative and impact assessment tool sets.
  • Define and implement effective preventative actions to prevent recurrence.
  • Manage multiple investigations to efficiently meet compliance deadlines and product release dates.
  • Collaborate with cross-functional teams to develop and track CAPA plans.
  • Identify and create trending rules that trigger corrective actions.
  • Analyze process data to identify major improvement opportunities.
  • Effectively utilize change management approach.
  • Develop training materials on root cause analysis tools and discrepancy and deviation processes.
  • Champion CAPA plans and implementation.
  • Provide communication plans for ongoing deviations and CAPAs.
  • Effectively create and communicate CAPA plans to responsible parties.
  • Oversee timely completion of deviations, CAPAs, and Change Controls.
Requirements
  • BS in Quality or 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 operations 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 Environment

While performing the duties of this job, the employee may 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 Requirements

The 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.

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