Senior QA Specialist - Validation & Process Lead

qualityconsultinggroup; Juncos (PR); On-site; USD 80,000 - 120,000; Full time

Job summary

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is seeking a talented QA professional to join our team in Puerto Rico & USA. You will approve process validation protocols and environmental reports, lead investigations, and own site quality program procedures.

The role requires a Bachelor's degree and 6 years of related experience, with strong regulatory knowledge and project management skills.

Qualifications

• Bachelor's degree in related area.
• 6 years of directly related experience.
• Experience in commissioning and qualification, equipment validation, QRAES, Kneat, GDP, Change Controls, SOPs, etc.
• Project management skills.
• Strong organizational skills and ability to follow assignments to completion.
• Knowledge of manufacturing and distribution processes, QA, QAL, validation and processes development.
• Ability to interact with regulatory agencies.
• Strong word processing, presentation, database and spreadsheet skills.
• Strong written and oral communication, facilitation and presentation skills.
• Advanced data trending and evaluation.
• Ability to evaluate compliance issues.

Responsibilities

• Approve process validation protocols and reports for manufacturing processes.
• Represent Quality on incident triage team.
• Approve Environmental Characterization reports.
• Release of sanitary utility systems.
• Approve planned incidents.
• Represent QA on NPI team.
• Lead investigations.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.

Skills

Bachelor degree knowledge

Documentation & data analysis

Regulatory interaction

Project management

Communication skills

Process validation

Validation execution

Quality systems

Investigation leadership

Attention to detail

Education

Bachelor's degree in related area

Tools

Kneat

QRAES

Good Documentation Practices

Change Controls

SOPs

Job description

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is seeking a talented QA professional to join our team in Puerto Rico & USA. You will approve process validation protocols and environmental reports, lead investigations, and own site quality program procedures.

The role requires a Bachelor's degree and 6 years of related experience, with strong regulatory knowledge and project management skills.