Quality Assurance Investigator

3 weeks ago

Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full time
Job Title: Quality Control Compliance Investigator

Lynkx 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, discrepancies, and other events to improve processes and ensure compliance.

Key Responsibilities:
  • Determine the causes and preventative actions of deviations, non-conformances, OOS, OOT, 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.
  • Manage 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.
Requirements:
  • BS in a Quality/Process related field or equivalent experience.
  • 3-5 years of experience in quality control or quality assurance within the bio-pharma, biologics, or pharmaceutical industry or equivalent experience.
  • Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA.
  • Must have technical experience writing and assessing deviations, investigations, and Out of Specifications.
  • Must be able to analyze data/information and to assess and resolve complex problems.
  • Strong knowledge and understanding of U.S. and international cGMPs, ICH, and other regulations applicable to clinical and commercial manufacturing.
  • Knowledge of operational processes and controls in non-sterile and sterile operations.
  • 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.
  • Training; GMP Training, Quality Systems Training (Deviation/CAPA), Safety Training, Working Environment.

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