Investigation Lead

QRC Group, Inc; Manatí (PR); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Learning & development

Collaborative work environment

Projects with industry-leading clients

Job summary

QRC Group, LLC seeks an Investigation Lead to provide scientific and operational expertise for manufacturing investigations in sterile and non-sterile operations. You will coordinate information, ensure timely closure of Quality Events, and support regulatory submissions.

The role requires a Bachelor's in Science, Pharmacy, or Engineering, 5 years in parenteral manufacturing, 1 year in investigation processes, and strong English/Spanish communication skills.

Qualifications

• Bachelor's degree in Science, Pharmacy, or Engineering.
• Five years of experience in a parenteral manufacturing facility.
• At least one 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 teamwork.
• Excellent written and verbal communication in Spanish and English.

Responsibilities

• Lead manufacturing investigations (Quality Events) and coordinate information gathering.
• Ensure QEs, NTRs, and NOEs are completed and closed timely.
• Review regulatory submissions related to the area of responsibility.
• Lead QE and CAPA trend evaluations.
• Participate in regulatory inspections when necessary.
• Support site initiatives and other business needs.

Skills

Technical writing

Presentation skills

Statistical analysis

Interpersonal skills

Education

Bachelor's degree in Science, Pharmacy, or Engineering

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

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

Job Description

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.

• 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.

Qualifications

• 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.

Additional Information

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.