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 manufacturing investigations ( Quality Events , or QEs) and facilitate the collection and coordination of information required to support those investigations. Responsibilities Ensure that all QEs, NTRs, and NOEs are completed and closed within the established timeframe, using the appropriate tools to prevent recurrence. Review and provide input to regulatory submissions applicable to the area of responsibility. Lead QE and CAPA trend evaluations . Participate in regulatory inspections when necessary. Support site initiatives and other assignments based on business needs. Requirements Bachelor's degree in Science, Pharmacy, and/or Engineering. Five (5) years of experience in a parenteral manufacturing facility . At least one (1) year of experience in the investigation process . Strong technical writing and presentation skills. Ability to interpret and analyze statistical data. Knowledge of cGMPs, OSHA, EPA, and other regulatory standards. Proficiency with Microsoft Word, Excel, and PowerPoint. Excellent interpersonal skills and a teamwork-oriented approach. Excellent written and verbal communication skills in Spanish and English.
QRC group is a life science firm dedicated to provide services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.
Our services and solutions include:
Process and Laboratory Investigation
• Corrective and Preventive Action (CAPA)
• Change Control
• Training
• Document Management Control
• QA Laboratory
• Methodology Transfer and Validation
• Instrument Calibration
• Validation and Training in Chromatographic Data Acquisition System
• Cleaning Validation
• Automation Engineering
• Quality Systems
