Study Director - Sterilization

Job Description

Study Director I

Classification:

Schedule:

Traditional

Job Summary:

The Study Director has overall responsibility for the technical conduct of all assigned tests as well as for the review, interpretation, analysis, documentation, and reporting of results.

The study director is the single point of study control.

The study director ensures all assigned studies are completed on time.

Essential Duties:

Scientific/General


* Ensure reports are compliant with current procedures.


* Ensure final reports accurately reflect the data, results, and conclusions of the testing.


* Act as a final signature for assigned studies.


* Collaborate on Customer Specification Sheets (CSS) etc.

as assigned.


* Ensure sample and data traceability are maintained throughout testing.


* Ensure calculations and statistics accurately reflect the raw data.


* Ensure accuracy of raw data.


* Ensure test controls and monitors are accurately recorded and reviewed.


* Collaborate within the Quality Event (QE) process.


* Read and maintain an understanding of validation procedures.


* Collaborate with document owners on Standard Test Procedures (STP) as assigned.

Regulatory Compliance


* Know and follow applicable regulatory requirements (GMP, GLP, ISO, etc.).



* Know and follow company policies and procedures.


* Ensure that test procedures are approved, communicated to, and followed by analysts.


* Ensure all data are accurately and concurrently recorded.



* Ensure unforeseen circumstances or events are recorded and that corrective action is taken.


* Complete required training on time.

Customer Service


* Uphold the NL service standard.


* Communicate regularly with sponsors as needed to relay study updates and CSS details.


* Meet or exceed sponsor expectations.


* Collaborate with the Sales department on testing quotes.


* Maintain a general understanding of company pricing and credit policies.


* Review and update study information in CRM and/or other laboratory systems.

Project Management


* Coordinate workflow to ensure sponsor expectations are met.

Professionalism


* Keep current with technical and scientific information.


* Ensure analysts understand testing performed on behalf of the study director.



* Attend work regularly and reliably.


* Adhere to all policies and procedures.


* Perform other duties as assigned

Nelson core competencies:

Common requirements for positions at Nelson Labs are:


* Integrity


* Quality


* People


* Fun

Competencies of this position

Technical


* Knowledge of laboratory testing, equipment, procedures, and basic math sufficient to direct and oversee assigned testing.


* Ability to follow written procedures.


* Good documentation practice (GDP).


* Effective critical thinking, problem-solving, and decision-making skills.


* Ability to learn and comprehend d...