Process Area Specialist

Position: Process Area Specialist I
Job Title:

Deviation Investigator

Location:

Clayton, NC 27527

Duration: 12 Months (Possibility of extension depending upon business requirements and performance)

Shift: 8 - 5

Top skills per manager:

• Deviation investigation or QA experience
• Systematic problem solving
• Pharma experience

Purpose:

• Support people, equipment and processes for our operations areas to meet business and regulatory requirements.

Relationships:

• Manager. The role is responsible for collaborating with stakeholders related to assigned area.

Essential Functions:

• Work directly with production and QA to support deviation investigations, quick containments and root cause analysis
• Ensure compliance with standards
• Identify process needs and improvement opportunities for routine to minimally complex matters
• Perform process confirmations to ensure compliance and process improvements
• Responsible for reviewing BPRs as necessary
• Follow all safety & environmental requirements in the performance of duties
• Other duties, as assigned

Physical Requirements:

• Ability to work in an open office environment with the possibility of frequent distraction
• NOT
  
  REQUIRED:
  
  vision to 20/20 or 20/25
• NOT
  
  REQUIRED:
  
  color vision

Qualifications:

• Associate's degree in technology (engineering, technology or related field of study preferred) from an accredited university required
• May consider a High School Diploma or equivalent with a minimum of two (2) years of manufacturing experience required, preferably in a pharmaceutical manufacturing environment.
• Minimum of one (1) year of manufacturing experience in a pharmaceutical manufacturing environment preferred
• Excellent written communication skills required
• GMP knowledge preferred
• System knowledge preferred
• Manufacturing experience preferred
• Pharmaceutical manufacturing experience a plus