Hybrid Study Director - Routine Chemistry bei Sotera Health
Sotera Health · Salt Lake City, Vereinigte Staaten Von Amerika · Hybrid
- Junior
- Optionales Büro in Salt Lake City
The Laboratory Study Leader has overall responsibility for the technical conduct of all assigned tests of medical devices and/or pharmaceuticals as well as for the review, interpretation, analysis, documentation, and reporting of results. The Study Leader is the single point of study control. They ensure all assigned studies are completed on time.
A Laboratory Study Leader serves as a Subject Matter Expert (SME) both internally and externally for the testing they oversee and related industry regulations. They will represent well the testing they oversee both verbally and in writing.
This role aligns to our Routine Chemistry Section:
When receiving raw materials, Nelson Laboratories performs vendor qualifications in order to approve suppliers of pharmaceutical actives and excipients by using multiple wet chemistry techniques, both qualitative and quantitative. Examples of tests performed include: Identification tests, Iron, Lead, Arsenic, Fats and Fixed Oil tests, titrations, etc.
Education and experience requirements:
- B.S. degree (Chemistry or relevant Life Science strongly preferred) and 2+ yrs applicable laboratory coordination experience (medical device or pharmaceutical product testing preferred)
- OR
- High School diploma or GED and 6 yrs years applicable laboratory study leadership experience (medical device or pharmaceutical product testing preferred)
Essential Duties:
- Customer Service - Serve as a technical and scientific point of contact on both video conference calls and in person client visits.
- Serve as the subject matter expert (SME) on assigned standards and apply them appropriately to laboratory testing, providing guidance to lab analysts.
- Identify and resolve complex scientific problems.
- Actively participate in business strategies specific to the respective scientific department
- Own section test method and equipment validations, including procedure development.
- Regulatory & Compliance - Address findings from internal and external/regulatory audits & Assist with CAPA assignments as needed.
- Project Management - Coordinate with clients and other sections regarding test requirements for routine and non-routine studies.
Work Environment:
This job operates in a professional laboratory environment. This role routinely uses standard office and lab equipment including but not limited to computers, telephones, microscopes, micropipettes, pipette aids, various hand tools, and analytical equipment.
The possibility exists for exposure to biological and chemical hazards, exposure to carcinogenic compounds and other environmental aspects which may be considered unfavorable. Employees are expected to follow Biosafety and Chemical Hygiene policies, practices and procedures.
Sotera Health offers a competitive benefits package that includes:
Pay Rate: $25.50 per hour
- Medical, Rx, Dental, Vision, Disability, Life Insurance, Health Savings and Flexible Spending Accounts
- 401(k) program with Company match that immediately vests
- Paid holidays, vacation and sick time
- Free financial planning assistance
- Paid parental leave
- Education assistance
- Voluntary benefits including Critical Illness, Accident, Hospital Indemnity and Pet Insurance
- Employee Assistance Program (EAP)
About Company
Safeguarding Global Health® - with every test we complete.
