Sr Specialist QA - 35711

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 is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the project management involved.

Position Summary

The Sr Specialist QA is responsible for supporting Quality Assurance activities associated with validation, commissioning, qualification, quality systems, and compliance initiatives within a regulated manufacturing environment. This role ensures that processes, equipment, facilities, utilities, and computerized systems comply with current regulatory requirements, internal procedures, and industry standards. The incumbent will provide quality oversight for validation activities, document management, risk assessments, change controls, and continuous improvement initiatives while promoting data integrity and Good Documentation Practices (GDP).

Responsibilities

• Provide Quality Assurance oversight and support for Facilities and Utilities Commissioning and Qualification activities.
• Review and approve validation lifecycle documentation, including protocols, reports, discrepancies, and associated records.
• Support and evaluate Computer System Validation (CSV) activities for manufacturing and quality systems.
• Ensure compliance of equipment validation processes with applicable procedures and regulatory requirements.
• Participate in and facilitate risk assessments to support validation, qualification, and quality decisions.
• Review and approve change controls, ensuring appropriate impact assessments, risk evaluations, and implementation plans.
• Review, revise, and approve controlled documents, including Standard Operating Procedures (SOPs), protocols, reports, and work instructions.
• Ensure adherence to Good Documentation Practices (GDP) and Data Integrity requirements across all quality systems and documentation.
• Provide quality oversight for syringe and vial inspection processes to ensure compliance with established standards and procedures.
• Utilize and maintain quality and validation systems such as KNEAT, CDOCS, SCADA, TrackWise, and Maximo.
• Collaborate with cross-functional teams including Manufacturing, Engineering, Validation, and Operations to support site objectives.
• Apply decision-making methodologies and risk management principles to support quality and compliance-related activities.
• Ensure compliance with cGMPs, company policies, and applicable regulatory requirements.

Minimum Qualifications

• Doctorate degree and 2 years of directly related experience; OR
• Master’s degree and 4 years of directly related experience; OR
• Bachelor’s degree and 6 years of directly related experience

This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.