QA Operations Associate
Novartis
3 months ago
On-site
Millburn, NJ
$29.13 - $54.13 USD yearly
Operations
Key Responsibilities:
- Provide shopfloor quality oversight of production, quality control, and supply chain departments to ensure full adherence to cGMP (including data integrity); ensure timely escalation of applicable incidents.
- Support QA Operations programs for batch release and shopfloor activities, including ViMOS, GEMBA walkthroughs, equipment/area/utility out-of-service program, QA area release of classified/unclassified areas, QA media fill oversight, event triage, and support of routine operations.
- Assist functional areas with timely, compliant raw material disposition; ensure site personnel comply with current procedures and GMP requirements.
- Oversee Final Product dose storage after completion of manufacturing activities.
- Review facility alarms, assess impact, and escalate any GxP impact immediately.
- Perform live review of manufacturing/packaging batch records ahead of batch release; escalate discrepancies immediately.
- Support FDA/regulatory interactions for Millburn RLT Site products to enable successful submissions and inspections.
- Partner with QA Operations as a business partner focused on safety, quality, delivery to patients, cost, compliance, and data integrity.
- Support continuous quality improvement for manufacturing operations; partner with production, engineering, and supply chain teams to improve efficiency and monitor/escalate as needed.
Essential Requirements / Qualifications:
- Bachelor’s degree (Life Sciences, Chemistry, or related). In lieu of degree: 3–5 years in pharma industry role including quality assurance experience.
- 2+ years’ experience in GxP (bio)pharmaceutical or API manufacturing operations.
- 1+ years’ experience in a quality assurance role (preferred).
- Experience collaborating across boundaries; functional breadth.
- QA/QC experience in pharma with environmental monitoring and cleanliness zones.
Application Instructions:
- Apply only if Millburn is accessible for you (no relocation support offered).
- Provide shopfloor quality oversight of production, quality control, and supply chain departments to ensure full adherence to cGMP (including data integrity); ensure timely escalation of applicable incidents.
- Support QA Operations programs for batch release and shopfloor activities, including ViMOS, GEMBA walkthroughs, equipment/area/utility out-of-service program, QA area release of classified/unclassified areas, QA media fill oversight, event triage, and support of routine operations.
- Assist functional areas with timely, compliant raw material disposition; ensure site personnel comply with current procedures and GMP requirements.
- Oversee Final Product dose storage after completion of manufacturing activities.
- Review facility alarms, assess impact, and escalate any GxP impact immediately.
- Perform live review of manufacturing/packaging batch records ahead of batch release; escalate discrepancies immediately.
- Support FDA/regulatory interactions for Millburn RLT Site products to enable successful submissions and inspections.
- Partner with QA Operations as a business partner focused on safety, quality, delivery to patients, cost, compliance, and data integrity.
- Support continuous quality improvement for manufacturing operations; partner with production, engineering, and supply chain teams to improve efficiency and monitor/escalate as needed.
Essential Requirements / Qualifications:
- Bachelor’s degree (Life Sciences, Chemistry, or related). In lieu of degree: 3–5 years in pharma industry role including quality assurance experience.
- 2+ years’ experience in GxP (bio)pharmaceutical or API manufacturing operations.
- 1+ years’ experience in a quality assurance role (preferred).
- Experience collaborating across boundaries; functional breadth.
- QA/QC experience in pharma with environmental monitoring and cleanliness zones.
Application Instructions:
- Apply only if Millburn is accessible for you (no relocation support offered).