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