Senior Quality Assurance Specialist – Sterile Manufacturing
Location: Morrisville, NC
Schedule: Monday–Friday, 8:00 AM – 5:00 PM
Pay Rate: $35–$45/hour
Type: 6-Month Contract (Fully Benefited)

Job Summary:
This on-site position is responsible for driving quality and compliance initiatives within a sterile pharmaceutical manufacturing environment. The Senior Quality Assurance (QA) Specialist ensures compliance with cGMP regulations and internal procedures by performing document review, internal audits, visual inspection of sterile drug products, and contributing to continuous improvement efforts. This role plays a key part in maintaining a strong quality culture and supporting regulatory inspection readiness, particularly in environments requiring Grade C gowning and aseptic handling.

Key Responsibilities:

• Perform quality review and approval of GMP documentation, including batch records, logbooks, forms, protocols, and reports.

  
  

• Issue and control GMP documents to support manufacturing operations in sterile cleanroom environments.

  
  

• Conduct visual inspections of parenteral drug products (qualification required) for defects or particulate contamination.

  
  

• Execute internal audits and support external client and regulatory inspections.

  
  

• Maintain and update quality databases and ensure proper document control.

  
  

• Provide floor support to manufacturing teams and guide adherence to aseptic techniques and cleanroom behavior.

  
  

• Assist in the development and revision of SOPs, forms, and quality procedures to meet regulatory standards and improve processes.

  
  

• Collaborate cross-functionally to support batch review, deviation resolution, CAPAs, training, and vendor qualification efforts.

  
  

• Serve as a mentor or resource for less experienced QA team members.

Qualifications:

• Bachelor’s degree in Chemistry, Biology, or a related field; Master’s degree preferred.

  
  

• Minimum 5+ years of GMP experience in quality assurance, preferably in sterile manufacturing.

  
  

• Familiarity with Annex 1, aseptic processing, and Grade C gowning requirements.

  
  

• Ability to meet visual inspection standards (20/20 corrected vision).

  
  

• Strong understanding of FDA and international cGMP regulations.

  
  

• Experience working in environments requiring strict contamination control.

Work Conditions & Physical Requirements:

• Full-time, 100% on-site position.

  
  

• Frequent standing, occasional sitting, walking, kneeling, or crouching.

  
  

• Regular lifting of up to 10–25 lbs; occasional lifting of up to 50 lbs.

  
  

• Exposure to cleanroom environments, moving equipment, potential chemical or biohazardous materials.

  
  

• Use of Personal Protective Equipment (PPE) required (gowns, respirators, gloves, etc.).

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