Hello,

We are hiring for a Quality Assurance Associate/Specialist for one of our prominent client based at Sanford, NC Below are the details: This is a 12 months contract job.

Responsibilities:

• The Sanford Engineering Systems investigation team is responsible for completing investigations for equipment/instrument failures along with human root causes when engineering personnel are involved.
• This position will report to the site's Engineering Systems Lead.
• The candidate will be responsible for performing thorough, detailed and timely investigations and generation of high quality and timely investigation reports.
• The individual will be expected to develop collaborative relationships with the colleagues within Engineering, Maintenance and Utilities (EMU) and the appropriate Quality representatives in order to facilitate investigations using common investigation tools (5 whys, fishbone diagrams, etc.).
• The incumbent will be expected to have experience in the area of quality and compliance and a working knowledge of the appropriate regulations.
• Additional responsibilities and expectations include: Have a fundamental understanding of the investigation process as it applies to manufacturing issue
• Have general understanding of equipment, instruments and systems involved in the manufacture of bio pharmaceutical.
• Be able to use that knowledge to investigate deviations to identify root cause.
• Be able to interview subject matter experts.
• Work with the appropriate people develop a corrective action
• Ensure their investigations are conducted with a strict adherence to appropriate quality and compliance standards

Qualifications:

• High school diploma
• quality investigations / CAPA / Root Cause in manufacturing setting.
• Preferred Skills:
• Experience completing investigations is highly desirable.
• Experience with Veeva Vault is a plus.
• Required Skills:

1. Compliance Investigations
2. All MS Office Products and Outlook including Teams
3. Excellent Technical Writing Skills, Communication - Written and Verbal,
4. Detail Oriented/Organized

Job Type: Contract

Pay: $20.00 - $27.00 per hour

Expected hours: 40 per week

Experience level:

• 1 year
• 2 years
• 3 years
• 4 years

Schedule:

• 8 hour shift

Education:

• High school or equivalent (Required)

Experience:

• Root cause analysis: 2 years (Required)
• Manufacturing: 2 years (Required)
• Quality Assurance equipment: 2 years (Required)
• SOP: 2 years (Preferred)
• CAPA: 2 years (Required)
• Document management systems: 2 years (Required)

Work Location: On the road