Specialist QA - 35619

Mirus Consulting Group; Juncos (PR); On-site; USD 95,000 - 130,000; Full time

Job summary

mîrus Consulting Group, a Humacao, Puerto Rico-based company, seeks a Specialist QA to provide quality oversight for regulated biopharmaceutical manufacturing. The role supports investigations, deviations, validations, and continuous improvement across sites and customers.

Responsibilities include leading complex investigations, reviewing change controls and risk assessments, and maintaining QA procedures in line with regulatory requirements.

Qualifications

• PhD or MS with relevant experience OR a BS with 4+ years in a biopharma/regulatory setting.
• Minimum 5 years of experience in biopharmaceutical, biotechnology, pharmaceutical, or related regulated industry.
• Experience working within a Quality Assurance organization.
• Strong experience supporting deviations, investigations, CAPAs, validation reports, equipment/utilities/facility qualifications, and change control processes.
• Experience operating in a highly regulated cGMP environment.
• Demonstrated knowledge of FDA, EMA and applicable regulatory requirements.
• Experience interacting with cross-functional teams in manufacturing, engineering, validation, and quality control.

Responsibilities

• Review and approve deviations, non-conformance investigations, CAPA records, and quality system documentation.
• Lead and support complex investigations, including root cause analysis and CAPA implementation.
• Review and approve change controls and associated supporting documentation.
• Review and approve risk assessments to ensure appropriate mitigation strategies.
• Own, maintain, and revise site Quality Program procedures in compliance with regulatory requirements and company standards.
• Serve as the QA representative on Incident Triage Teams and support escalation activities.
• Act as QA designee for the local Change Control Review Board (CCRB) in the absence of the QA Manager.
• Lead and support internal site audits and participate in regulatory inspections and customer audits.

Skills

Quality Assurance

cGMP knowledge

FDA/EMA guidance

Root cause analysis

CAPA management

Change control

Investigations leadership

Regulatory compliance

Education

Doctorate degree

Master's degree + 2 years experience

Bachelor's degree + 4 years experience

Bachelor's degree in Science/Engineering/Biology/Chemistry

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 Specialist QA is responsible for providing quality oversight and support for quality systems within a highly regulated biopharmaceutical manufacturing environment. This role ensures compliance with applicable regulatory requirements, internal procedures, and industry standards by supporting investigations, deviations, qualifications, validation activities, and continuous improvement initiatives.

Key Responsibilities

Quality Systems & Compliance

• Review and approve deviations, non-conformance investigations, CAPA records, and quality system documentation.
• Lead and support complex investigations, including root cause analysis and implementation of corrective and preventive actions.
• Review and approve change controls and associated supporting documentation.
• Review and approve risk assessments to ensure appropriate mitigation strategies are implemented.
• Own, maintain, and revise site Quality Program procedures in compliance with regulatory requirements and company standards.
• Serve as the QA representative on Incident Triage Teams and support escalation activities.
• Act as QA designee for the local Change Control Review Board (CCRB) in the absence of the QA Manager.
• Lead and support internal site audits and participate in regulatory inspections and customer audits.

Manufacturing Support

• Review and approve Manufacturing Procedures (MPs) and associated manufacturing documentation.
• Provide QA oversight for manufacturing operations and batch record review activities.
• Approve planned incidents and manufacturing-related investigations.
• Provide lot disposition decisions and authorize product lots for release and shipment.

Validation & Qualification Oversight

• Review and approve process validation protocols and final reports for manufacturing processes.
• Review and approve qualification protocols and reports associated with facilities, utilities, equipment, and manufacturing systems.
• Provide quality oversight and approval of Environmental Characterization reports.
• Support commissioning, qualification, and validation activities throughout the lifecycle of systems and processes.

Cross-Functional Support

• Represent Quality Assurance on New Product Introduction (NPI) teams.
• Partner with Manufacturing, Engineering, Validation, Facilities, and Automation organizations to ensure compliance with quality and regulatory requirements.

Qualifications

One of the following combinations of education and experience is required:

• Doctorate degree, OR
• Master's degree and 2 years of directly related experience, OR
• Bachelor's degree and 4 years of directly related experience, OR
  • Bachelor's degree in: Science, Engineering, Biology, Chemistry or related fields.
• Minimum of 5 years of experience in the biopharmaceutical, biotechnology, pharmaceutical, or related regulated industry.
• Experience working within a Quality Assurance organization.
• Strong experience supporting:
  • Deviations
  • Investigations
  • CAPAs
  • Validation reports
  • Equipment, utility, and facility qualifications
  • Change control processes
• Experience operating in a highly regulated cGMP environment.
• Demonstrated knowledge of FDA, EMA, and applicable regulatory requirements.
• Experience interacting with cross-functional teams in manufacturing, engineering, validation, and quality control.

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.