Title : Quality Affairs Specialist

Location : Iron Station, NC area

Schedule : M-F Full Time

Type : Direct Hire

Responsibilities :

The Quality Affairs Specialist performs various activities that ensure and support the regulatory compliance of the operation.

• Support the Complaint Intake and Closure process by interfacing with customers on complaints.
• Responsible for ensuring timely recognition of critical complaints, adverse events, and communication to Quality Management and Pharmacovigilance.
• Perform Complaint Investigations into customer complaints by reviewing documentation, examining retain samples, and working with internal departments to arrive at the root cause and recommend appropriate CAPA;

perform trending analysis; and respond to the complainants, as required.

• Annual Product Review generation : Prepare Annual Product Reviews according to the scheduled due dates. Perform Statistical Analysis, identify and evaluate product trends, and recommend CAPAs to management as required.
• Participate in Internal Audits including System Audits and Facility Walk-Throughs to assess compliance to cGMPs.
• Support Stability Function by working with Stability Staff to ensure required Stability Studies are Conducted and Reported to Authorities.

Work with Stability Equipment and Equipment Vendors to ensure Maintenance of Stability Equipment. Assist with routine Monitoring of Temperature and Humidity of Stability Storage Areas / Chambers, Investigations of Equipment Excursions, and Annual Reviews of all Stability Storage Areas / Chambers storage areas.

• Participate in Regulatory Field Actions : Participate in Field Actions such Recalls, Field Alerts, etc. as required.
• Other Duties as assigned by Manager.

Requirements :

• BA / BS in Chemistry / Biology / related science or Comparable Post Secondary Schooling with applicable industry experience
• At least 5 years industry experience with knowledge of Pharmaceutical Systems.
• Strong problem solving and investigative skills.
• Understanding of Regulatory Codes
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19 hours ago