Back to search
We are seeking an Investigation Lead to provide operational and scientific expertise,together with compliance knowledge, in support of manufacturing sterile and non-sterile operations. The resource will execute manufacturinginvestigations (Quality Events, or QEs) and facilitate the collection andcoordination of information required to support those investigations.
Responsibilities
- Ensure that all QEs, NTRs, and NOEs arecompleted and closed within the established timeframe, using the appropriatetools to prevent recurrence.
- Review and provide input to regulatorysubmissions applicable to the area of responsibility.
- Lead QE and CAPA trend evaluations.
- Participate in regulatory inspections whennecessary.
- Support site initiatives and other assignmentsbased on business needs.
Requirements
- Bachelor's degree in Science, Pharmacy, and/orEngineering.
- Five (5) years of experience in a parenteralmanufacturing facility.
- At least one (1) year of experience in the investigation process.
- Strong technical writing and presentationskills.
- Ability to interpret and analyze statisticaldata.
- Knowledge of cGMPs, OSHA, EPA, and otherregulatory standards.
- Proficiency with Microsoft Word, Excel, andPowerPoint.
- Excellent interpersonal skills and ateamwork-oriented approach.
- Excellent written and verbal communicationskills in Spanish and English.
Learn more about this Employer on their Career Site
