Lead Investigations

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

Job summary

QRC Group, LLC in Puerto Rico seeks an Investigation Lead to provide operational and scientific expertise in sterile and non-sterile manufacturing, while ensuring compliance with regulatory standards.

You will execute manufacturing investigations (QEs) and coordinate information; close QEs/NTRs/NOEs within timeframe; support regulatory submissions and inspections.

Qualifications

• Bachelor's degree in Science, Pharmacy, or Engineering.
• At least five years in parenteral manufacturing.
• Minimum one year in the investigation process.
• Strong technical writing and presentation abilities.
• Ability to interpret and analyze statistical data.
• Knowledge of cGMPs, OSHA, EPA and other standards.
• Proficiency with Word, Excel and PowerPoint.
• Excellent communication in Spanish and English.

Responsibilities

• Ensure QEs, NTRs, and NOEs are completed and closed on time.
• Review regulatory submissions within the area of responsibility.
• Lead QE and CAPA trend evaluations.
• Participate in regulatory inspections when needed.
• Support site initiatives and other business needs.

Skills

Technical writing

Presentation skills

Statistical analysis

Interpersonal skills

Teamwork

Bilingual Spanish/English

Education

Bachelor's degree in Science/Pharmacy/Engineering

Tools

MS Word

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.

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

Job Description

We are seeking an Investigation Lead to provide operational and scientific expertise, together with compliance knowledge, in support ofmanufacturing sterile and non-sterile operations. The resource will executemanufacturing 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.
• LeadQE and CAPA trend evaluations.
• Participate inregulatory inspectionswhen 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 aparenteral manufacturing facility.
• At least one (1) year of experience in theinvestigation 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

All your information will be kept confidential according to EEO guidelines.

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