Senior QA Specialist: Validation, Compliance & CSV

Mirus Consulting Group; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

mîrus Consulting Group in Humacao, Puerto Rico, seeks a Sr Specialist QA to support validation, commissioning and GDP compliance in a regulated manufacturing environment. You will oversee validation lifecycle documentation, risk assessments, change controls, and data integrity while promoting GDP across quality systems.

Collaborating with Manufacturing, Engineering, Validation, and Operations, you will ensure cGMP compliance and proper documentation, using KNEAT, CDOCS, SCADA, TrackWise, and

Qualifications

• Doctorate degree with 2 years of directly related experience; OR

Responsibilities

• Provide Quality Assurance oversight for Facilities and Utilities Commissioning and Qualification activities.
• Review and approve validation lifecycle documentation including protocols and reports.
• Support CSV activities for manufacturing and quality systems.
• Ensure equipment validation processes meet procedures and regulatory requirements.
• Participate in risk assessments to support validation, qualification, and quality decisions.
• Review and approve change controls with impact assessments and risk evaluations.
• Review, revise, and approve controlled documents such as SOPs and work instructions.
• Ensure GDP and Data Integrity across all quality systems and documentation.
• Provide quality oversight for syringe and vial inspection processes.
• Utilize systems like KNEAT, CDOCS, SCADA, TrackWise, and Maximo to support quality activities.
• Collaborate with Manufacturing, Engineering, Validation, and Operations to meet site objectives.
• Apply decision-making methodologies and risk management in quality activities.
• Ensure compliance with cGMPs and regulatory requirements.

Skills

Quality Assurance

Validation

GDP

Data Integrity

Risk Assessment

Change Controls

SOPs

Regulatory Compliance

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Tools

KNEAT

CDOCS

SCADA

TrackWise

Maximo

Job description

mîrus Consulting Group in Humacao, Puerto Rico, seeks a Sr Specialist QA to support validation, commissioning and GDP compliance in a regulated manufacturing environment. You will oversee validation lifecycle documentation, risk assessments, change controls, and data integrity while promoting GDP across quality systems.

Collaborating with Manufacturing, Engineering, Validation, and Operations, you will ensure cGMP compliance and proper documentation, using KNEAT, CDOCS, SCADA, TrackWise, and