Process Area Specialist I

Spectraforce Technologies, Inc.; Clayton (NC); On-site; USD 34,000 - 47,000; Full time

Job summary

Spectraforce Technologies, Inc. in Clayton, NC is seeking a Deviation Investigator for a 12-month assignment, with a shift from 8 to 5. You will work with production and QA to investigate deviations, establish quick containment, and perform root cause analysis to prevent recurrence.

Qualifications include an Associate's degree in technology or equivalent, plus manufacturing experience (pharma preferred) and strong written communication. GMP knowledge and system familiarity are considered a plus.

Qualifications

• Associate's degree in technology required
• Minimum of two years manufacturing experience, preferably in a pharmaceutical environment
• Minimum of one year manufacturing experience in a pharmaceutical environment preferred
• Excellent written communication skills required
• GMP knowledge preferred
• System knowledge preferred
• Manufacturing experience preferred
• Pharmaceutical manufacturing experience a plus

Responsibilities

• 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

Skills

Deviation investigation or QA

Systematic problem solving

Pharma experience

Education

Associate's degree in technology

High School Diploma with 2 years manufacturing experience

Job description

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