Investigation Lead

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

Log on now to our website http://www.**qrcgroup.com**/ to learn more about our services and solutions!

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.

• 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.

Benefits

What We Offer

• Opportunities for learning, development, and professional growth.
• A collaborative and supportive work environment.
• The opportunity to work with industry-leading clients on impactful projects.

Your information will be kept confidential according to EEO guidelines.