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QC Analyst Compliance Investigator

Location : Mahwah NJ US 07430
Job Type : Direct
Reference Code : 21149-AB1
Compensation : 75000.00 - 95000.00 USD/YEAR
Start Date : 08/19/2022
Hours : Full Time
Required Years of Experience : 3
Required Education : Bachelor of Science
Travel : No
Relocation : No
Job Industry : Pharmaceutical

Job Description :

  • Permanent position for a QC Analytical Compliance Investigator to lead investigations, including but not limited to deviations, non-conformances, and discrepancies.

  • Implement corrective and preventative actions (CAPA) to ensure compliance and improve processes.

  • Determine the causes and define and implement effective preventative actions of Deviations, Non-Conformances, OOS, OOT, field complaints and environmental excursion investigations.

  • Drive investigations to true root cause using appropriate investigation tools.

  • Collaborate with cross-functional teams to develop and track CAPA plans.

  • Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates.

  • Identify and create appropriate trending rules that trigger corrective actions.

  • Analyze process data and evaluate trends to identify major improvement opportunities.

  • Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy and deviation process.

  • Oversee timely completion of deviations, CAPAs, and Change Controls as necessary.

  • Provide communication plan for on-going deviations & CAPAs and communicate CAPA plan.

Required Qualifications :

  • Bachelor of Science in a Quality / Process related field.

  • Experience in GMP Operations and/or Quality Assurance in Cell Therapies, Biotechnology or Bio-Pharma.

  • Root cause analysis experience.

  • Experience using e-Quality Management Systems preferred.

  • Experience with Visio, Microsoft Project and Excel.

  • Analytical and problem-solving skills, strong written and oral communication skills.

  • Integrity, accountability and strong dedication to regulatory compliance.

  • Continuous improvement mindset.

  • Ability to work effectively as a team and independently.

Contact: Allan Berman

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