Specialist – Quality Control-1
| Company | Inventing for Life |
|---|---|
| Location | Durham, NC, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Mid Level |
Requirements
- B.S. in Biological Sciences, with minimum of 3 years of laboratory experience
- Experience with aseptic manipulations
- Experience with environmental monitoring activities
- Experience in sampling of clean utilities, including but not limited to compressed gases and water
- Good technical writing skills and high attention to detail
- Previous GMP-laboratory experience
- Work independently and within a team environment
Responsibilities
- Sampling of clean utilities including but not limited to compressed gas and water for injection
- Environmental monitoring of production and support areas, including sampling, processing of samples, and reporting results
- Participating in Environmental Monitoring Performance Qualification activities
- Microbiological testing in support of production media
- Participating in aseptic process simulations, including sampling, testing of simulation units, and reporting of data
- Schedule daily testing of laboratory samples based on internal metrics and production needs
- Author/review technical documents, standard operating procedures, change controls, and investigations for the performance of laboratory methods
- Initiates and contributes to laboratory investigations as needed and follows site procedures in the documentation of Quality Notifications and Corrective/Preventative Actions
- Execute test method qualification
- Trouble-shoot equipment issues as needed
- Laboratory maintenance including managing stock of reagents, consumables, and laboratory cleaning
- Train and mentor laboratory analysts on test methods, techniques, and good documentation practices
- Review of laboratory generated data and results
- Authorizing and approving of samples
- 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’s Divisional and Quality initiatives
- Additional project and routine testing support as required
- Other duties as requested by management to support effective laboratory operations and performance metrics
Preferred Qualifications
- Experience with responding to regulatory questions with multiple agencies (FDA, EMA, JNDA)
- Experience authoring technical documents supporting regulatory filings (IND, BLA)
- Experience with assay development, validation, or technical transfers
- Equipment Validation
- Knowledge of CFR, Eudralex, and Compendia testing specific to the pharmaceutical industry
- Experience in regulatory agency audits and/or regulatory filings
- Experience in technical writing, including Standard Operating Procedures, laboratory investigations, and method transfer/qualification reports
- Experience in training of personnel