Investigations Lead

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

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• At least one (1) year of experience in the investigation process

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• 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.