Mgr – Quality
| Company | Merck |
|---|---|
| Location | Durham, NC, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s |
| Experience Level | Senior |
Requirements
- B.S. or M.S. degree in Sciences with a minimum of 5 years of laboratory experience
- Experience with execution and trouble-shooting of microbiological testing
- Experience in Environmental Monitoring, including sampling, testing, and reporting.
- Experience with aseptic handling techniques
- Technical writing skills
- Previous GMP laboratory experience
Responsibilities
- Lead start-up new laboratories for microbiological testing and environmental monitoring
- Collaborate with internal customers and vendors to ensure successful execution of method transfer or method validation activities
- Apply project management concepts and techniques as they relate to laboratory testing start-up, regulatory requirements for method transfer/validation project timelines and budgeting
- Author/review technical documents, standard operating procedures, change controls, and investigations for the performance of laboratory methods
- Trouble-shoot laboratory process and equipment issues as needed
- Sample management
- Planning and test method execution to meet established delivery timelines
- Provide active support during audits and inspections (regulatory, internal, safety)
- Assist regulatory groups by providing documentation to support the approval of licensure supplements and new product license registrations
- Collaborate with Durham Laboratory Compliance to ensure adherence to regulatory requirements
- Support our Manufacturing Divisional and Quality initiatives
- Additional project and routine testing support as required by laboratory testing requirements
Preferred Qualifications
- Leadership experience
- Experience in new assay development, validation, and/or technology transfer
- Experience authoring technical documents supporting regulatory filings (FDA, EMA, JNDA)
- Knowledge of CFR, Eudralex, and Compendia testing specific to the pharmaceutical industry
- Experience in regulatory agency audits and/or regulatory filings
- Experience with Lean Six-sigma and problem-solving tools