Investigations Lead
QRC Group
Manati, Puerto Rico | Posted on 08/27/2026 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. #J-18808-Ljbffr QRC Group
Vacancy posted 3 days ago
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