At Nelson Laboratories, a Sotera Health Company, our employees are part of an industry-leading, global provider of sterility assurance, medical device evaluation services and expert advisory services.
Our employees receive competitive pay, growth and learning opportunities, insurance benefits, tuition reimbursement, paid holidays, time-off and the opportunity to attend many company-sponsored employee and family events.
Nelson Labs employees play a critical role in reaching our mission of: Safeguarding Global Health.
The Study Director has overall responsibility for the technical conduct of all assigned tests as well as for the interpretation, analysis, documentation, and reporting of results. The study director is the single point of study control.
Essential Job Duties
- Ensure procedures and reports are current with published methods.
- Ensure final reports accurately reflect the data, results and conclusions of the testing.
- Prepare and review written procedures including SOPs, STPs, PDSs, SDSs, etc.
- Ensure method validation and test controls are adequate to support the test methodology.
- Ensure sample and data traceability are maintained throughout testing.
- Ensure calculations and statistics accurately reflect the raw data.
- Ensure test controls and monitors are accurately recorded and reviewed.
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 and followed.
- Ensure all data are accurately and concurrently recorded.
- Ensure unforeseen circumstances or events are recorded and that corrective action is taken.
- Keep current with technical and scientific information.
- Ensure support personnel have adequate knowledge and training to perform their job functions.
- Complete required training on time.
- Uphold the NLI service standard.
- Communicate regularly with sponsors.
- Meet or exceed sponsor expectations.
- Work with SL/DM in managing test work flow to ensure sponsor expectations are met.
- Meet turnaround time deadlines.
- Perform other duties as assigned.
A.A. /A.S. and two years NLI laboratory experience;
Or, B.S. degree (microbiology or biological science strongly preferred or NLI equivalent) and four months NLI experience;
Or, five years NLI laboratory experience in addition to demonstrated proficiency for test coordination.
Must be able to stand/walk for 40% of the day and 60% sitting or at a computer. Heavy lifting not required but must be able to occasionally lift a minimum of 30lbs.
This job operates in a professional laboratory environment. Meaning:
- The environment is warm and humid.
- This role routinely uses standard office equipment and lab equipment including but not limited to, computers, keyboards, computer mouse, telephones, photocopiers, pipette aids and various hand tools.
- Possibility exists for exposure to biological and chemical hazards, exposure to carcinogenic compounds and other environmental aspects which may be considered unfavorable.
- Employee is expected to follow Biosafety and Chemical Hygiene policies, practices and procedures.