Quality Assurance Specialist

Job Summary:

The Quality Assurance Specialist is responsible for developing, implementing, and maintaining a cGMP Quality System to meet the requirements of 21CFR210, 21CFR211, Regulatory Agencies, and customer expectations.

• · Review and approve/reject all raw materials and packaging components.
  
• · Respond to customer complaints.
  
• · Administer/review complaint investigations.
  
• · Review all investigations as necessary.
  
• · Create change controls.
  
• · Revise all packaging and manufacturing batch records.
  
• · Review and approve monographs, specification sheets, and analysis sheets.
  
• · Handle all quarantine shipments.
  
• · Audit manufacturing processes.
  
• · Review and approve new labeling.
  
• · Coordinate recalls.
  
• · Review warehouse temperature monitoring data and charts.
  
• · Support and provide assistance to the Quality Assurance Manager as necessary.
  
• · Perform investigations, determine root cause, and develop CAPAs
  

Required Skills/Abilities:

• · Excellent verbal and written communication skills in English.
  
• · Excellent management and teamwork skills.
  
• · Excellent organizational skills and attention to detail.
  
• · Excellent time management skills with a proven ability to meet deadlines.
  
• · Ability to function well in a high-paced and at times stressful environment.
  
• · Ability to understand and follow all Standard Operating Procedures and current Good Manufacturing Practices provided by the Company.
  
• · Understanding of quality systems including change control, deviations and CAPAs.
  
• · Ability to handle multiple tasks concurrently and complete them in a timely manner.
  
• · Strong written and verbal language skills to effectively read and write SOPs and related lab reports, and communicate with personnel at all levels in the organization.
  

Requirements

Education and Experience

• · B.S. in Chemistry, Biology, or equivalent work experience in a related field.
  
• · Experience in computer software, such as Microsoft applications.
  
• · Expert knowledge of cGMP regulations.
  
• · Expert knowledge and understanding of FDA policies and regulations.
  
• · Pharmaceutical experience required.
  

Job Type: Full-time

Pay: $58,000.00 - $62,000.00 per year

Ability to commute/relocate:

• Gulfport, MS 39501: Reliably commute or planning to relocate before starting work (Required)
  

Education:

• Bachelor's (Preferred)
  

Experience:

• Quality assurance: 3 years
  
• Pharmaceutical Investigations: 3 years 
  

Benefits

Benefits:

• Dental insurance
  
• Health insurance
  
• Life insurance
  
• Paid time off
  
• Vision insurance