Investigation Specialist

QRC Group, Inc; Carolina (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

QRC Group, LLC is seeking an Investigations Specialist to conduct thorough investigations of manufacturing issues and deviations, generate high-quality investigation reports, and support CAPA activities in regulated environments.

The role requires a science background, 5+ years in manufacturing investigations, bilingual Spanish/English, ability to travel to the United States immediately, and strong knowledge of complaints and deviation processes.

Qualifications

• Bachelor's degree in Science and five (5) years of experience in manufacturing investigations.
• Background in biology or chemistry and investigations.
• Bilingual (Spanish / English).
• Computer literacy.
• Available to travel to the United States immediately.

Responsibilities

• Understand the investigation process as it applies to manufacturing issues and complaints.
• Understand the processes and systems involved in the manufacture of biopharmaceutical products.
• Investigate process deviations and atypical/out-of-specification results and identify root cause.
• Conduct investigations with strict adherence to the applicable quality and compliance standards.
• Develop and document corrective and preventive actions (CAPA) and verify their effectiveness.
• Coordinate with Subject Matter Experts (SMEs) across functions to gather and verify the information required for the investigation.
• Exercise judgment in developing practices, techniques, and evaluation criteria for obtaining results.

Skills

Regulated industries experience

Investigations in manufacturing

Biology background

Chemistry background

Bilingual Spanish/English

Travel readiness

Computer literacy

Education

Bachelor's degree in Science

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

Investigations Specialist with experience in regulated industries and strong knowledge of complaints and deviation processes. The specialist will be responsible for performing thorough, detailed, and timely investigations and for the generation of high-quality, timely investigation reports. Must be available to travel to the United States immediately.

Responsibilities

• Understand the investigation process as it applies to manufacturing issues and complaints.
• Understand the processes and systems involved in the manufacture of biopharmaceutical products.
• Investigate process deviations and atypical/out-of-specification results and identify root cause.
• Conduct investigations with strict adherence to the applicable quality and compliance standards.
• Develop and document corrective and preventive actions (CAPA) and verify their effectiveness.
• Coordinate with Subject Matter Experts (SMEs) across functions to gather and verify the information required for the investigation.
• Exercise judgment in developing practices, techniques, and evaluation criteria for obtaining results.

Qualifications

• Bachelor's degree in Science and five (5) years of experience in manufacturing investigations.
• Background in biology or chemistry and investigations.
• Bilingual (Spanish / English).
• Computer literacy.
• Available to travel to the United States immediately.

Additional Information

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