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

• Microsoft Software

• ScienTek Stability System Software

• SAS® Software

• Veeva Software

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.