Investigation Lead – Parenteral Manufacturing & CAPA

QRC Group; Northern (KY); Hybrid; USD 110,000 - 140,000; Full time

Job summary

QRC Group in Manati, Puerto Rico seeks an Investigation Lead to provide operational and scientific expertise, together with compliance knowledge, in support of manufacturing sterile and non-sterile operations. The role focuses on conducting manufacturing investigations (Quality Events) and coordinating information for closure.

The candidate will lead QE/CAPA trend evaluations, review regulatory submissions, and participate in regulatory inspections, while supporting site initiatives and other

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.

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.

Skills

Statistical analysis

Technical writing

Regulatory knowledge

Bilingual English/Spanish

Education

Bachelor's degree in Science/Pharmacy/Engineering

Job description

QRC Group in Manati, Puerto Rico seeks an Investigation Lead to provide operational and scientific expertise, together with compliance knowledge, in support of manufacturing sterile and non-sterile operations. The role focuses on conducting manufacturing investigations (Quality Events) and coordinating information for closure.

The candidate will lead QE/CAPA trend evaluations, review regulatory submissions, and participate in regulatory inspections, while supporting site initiatives and other