Investigator Initiated Research (IIR) Associate - Opportunity to Make a Difference

Job Title:Investigator Initiated Research (IIR) Associate

Desired Start Date: 4/22/2024

End Date: 10/19/2025

Hrs/Wk: 40.00

Location: Sanford, North Carolina

Rate Card Category 2: Level III (5-7 years)

Job Description:

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. To know what facts you require, can separate out opinions from facts, use investigator tools to determine root cause, get area owner and Maintenance agreement, author the technical report, and obtain QA approval all under 30-days. Investigators juggle up to 7 investigations simultaneously. This is a very intense job that requires competence. Quickly adapt and learn client's methodology and work independently.

Additional responsibilities and expectations include:
" Have a fundamental understanding of the investigation process as it applies to manufacturing issues
" 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

Required Skills:
1. Compliance Investigations (Working experience vs familiarity)
2. All MS Office Products and Outlook including Teams
3. Excellent Technical Writing Skills, Communication - Written and Verbal,
4. Detail Oriented/Organized

Preferred Skills:
1. Experience completing investigations is highly desirable.
2. Experience with Veeva Vault is a plus.

Interview Process:
Panel Interview via Teams

Work Environment:

Onsite

What will the resource be working with, or, have exposure to?:

N/A

Will overtime be needed?:

Yes

If Yes, how many hours of overtime (on average) per week?:

up to 2 hours per week could be possible

What is the minimum education experience required?:

BA/BS