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Specialist Quality Control - 35983
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 Quality Control is responsible for supporting Quality Control operations with a strong focus on deviation management, laboratory investigations, and compliance within a regulated manufacturing environment. This role will collaborate with cross-functional teams to ensure timely resolution of quality events, maintain compliance with applicable procedures and regulatory requirements, and support continuous improvement initiatives. Experience in microbiology, analytical testing, and laboratory systems is highly desirable.
Key Responsibilities
Position Summary
The Specialist Quality Control is responsible for supporting Quality Control operations with a strong focus on deviation management, laboratory investigations, and compliance within a regulated manufacturing environment. This role will collaborate with cross-functional teams to ensure timely resolution of quality events, maintain compliance with applicable procedures and regulatory requirements, and support continuous improvement initiatives. Experience in microbiology, analytical testing, and laboratory systems is highly desirable.
Key Responsibilities
- Lead and manage Quality Control deviations.
- Serve as the primary Quality Control representative for deviation processes, ensuring timely closure and compliance with site procedures and regulatory expectations.
- Utilize scientific and technical knowledge to evaluate issues related to Microbiology testing, HPLC analyses, and analytical laboratory methods.
- Review laboratory data and analytical results to identify trends, potential risks, and opportunities for continuous improvement.
- Collaborate with Quality Assurance, Manufacturing, Validation, and other cross-functional teams to resolve quality events and implement effective corrective actions.
- Support Change Controls, Risk Assessments, and CAPA activities associated with Quality Control operations.
- Ensure compliance with cGMP regulations, data integrity requirements, site procedures, and global quality standards.
- Support internal audits, regulatory inspections, and responses to quality-related observations.
- Provide technical support and guidance regarding microbiological and analytical testing investigations.
- Doctorate degree OR
- Master’s degree and 2 years of directly related experience OR
- Bachelor’s degree and 4 years of directly related experience
- Hands-on experience managing Quality Control deviations in a pharmaceutical, biotechnology, or medical device environment.
- Strong background in Microbiology laboratory testing and investigation activities.
- Experience operating and troubleshooting HPLC systems.
- Knowledge of analytical laboratory methods, method troubleshooting, and data interpretation.
- Experience with OOS, OOT, CAPA, Change Control, and Risk Assessment processes.
- Strong investigation, technical writing, and root cause analysis skills.