Sr. Quality Assurance Specialist – Product Release
Job DescriptionSr. Quality Assurance Specialist – Product Release
📍 Puerto Rico Full-Time On-Site (Hato Rey, PR)
GRC Executive is conducting a confidential search for a Sr. Quality Assurance Specialist – Product Release on behalf of an established organization within the pharmaceutical industry.
This position will play a critical role in ensuring that pharmaceutical products meet all applicable quality, regulatory, and GMP requirements prior to release and distribution.
The ideal candidate brings strong pharmaceutical Quality Assurance experience, particularly in Product Release, GMP, Quality Systems, Master Batch Record review, Change Control, Validation, and regulatory compliance.
Key Responsibilities
- Review and approve product batches for release and distribution.
- Review and approve Master Batch Records (MBRs) and supporting documentation.
- Ensure compliance with GMP, FDA regulations, internal procedures, and Quality Management System (QMS) requirements.
- Support Quality Systems including Change Control, Risk Management, Trend Analysis, Annual Product Review (APR), and Labeling.
- Evaluate manufacturing processes, equipment qualification, and validation activities.
- Provide QA oversight and guidance during product development and onboarding.
- Review validation protocols, analytical methods, specifications, and supporting data.
- Support investigations and corrective/preventive actions when quality issues are identified.
- Analyze quality and operational data, including complaints, audit findings, and supplier performance.
- Identify opportunities for continuous improvement across Quality and Operational processes.
- Collaborate with Manufacturing, Operations, Technical teams, suppliers, and other stakeholders to resolve quality issues.
- Provide backup support to QA management and influence cross-functional teams to drive accountability and compliance.
Qualifications
- Bachelor’s degree in Science, Engineering, or a related Life Sciences discipline.
- 5–7 years of professional experience within the pharmaceutical industry.
- Strong experience with GMP and Quality Management Systems (QMS).
- Knowledge of FDA regulations and pharmaceutical quality requirements.
- Experience with Product Release and Master Batch Record review strongly preferred.
- Experience with Change Control, Validation, Risk Management, investigations, and quality documentation.
- Ability to work independently and effectively influence cross-functional teams.
- Strong analytical, problem-solving, and communication skills.
- Fluency in English required.
- ASQ certification (CQE, CQA, or similar) is a plus.
Work Environment
This is an on-site position, Monday through Friday, in Puerto Rico. Occasional travel may be required.
Sr. Quality Assurance Specialist – Product Release
📍 Puerto Rico Full-Time On-Site (Hato Rey, PR)
GRC Executive is conducting a confidential search for a Sr. Quality Assurance Specialist – Product Release on behalf of an established organization within the pharmaceutical industry.
This position will play a critical role in ensuring that pharmaceutical products meet all applicable quality, regulatory, and GMP requirements prior to release and distribution.
The ideal candidate brings strong pharmaceutical Quality Assurance experience, particularly in Product Release, GMP, Quality Systems, Master Batch Record review, Change Control, Validation, and regulatory compliance.
Key Responsibilities
- Review and approve product batches for release and distribution.
- Review and approve Master Batch Records (MBRs) and supporting documentation.
- Ensure compliance with GMP, FDA regulations, internal procedures, and Quality Management System (QMS) requirements.
- Support Quality Systems including Change Control, Risk Management, Trend Analysis, Annual Product Review (APR), and Labeling.
- Evaluate manufacturing processes, equipment qualification, and validation activities.
- Provide QA oversight and guidance during product development and onboarding.
- Review validation protocols, analytical methods, specifications, and supporting data.
- Support investigations and corrective/preventive actions when quality issues are identified.
- Analyze quality and operational data, including complaints, audit findings, and supplier performance.
- Identify opportunities for continuous improvement across Quality and Operational processes.
- Collaborate with Manufacturing, Operations, Technical teams, suppliers, and other stakeholders to resolve quality issues.
- Provide backup support to QA management and influence cross-functional teams to drive accountability and compliance.
Qualifications
- Bachelor’s degree in Science, Engineering, or a related Life Sciences discipline.
- 5–7 years of professional experience within the pharmaceutical industry.
- Strong experience with GMP and Quality Management Systems (QMS).
- Knowledge of FDA regulations and pharmaceutical quality requirements.
- Experience with Product Release and Master Batch Record review strongly preferred.
- Experience with Change Control, Validation, Risk Management, investigations, and quality documentation.
- Ability to work independently and effectively influence cross-functional teams.
- Strong analytical, problem-solving, and communication skills.
- Fluency in English required.
- ASQ certification (CQE, CQA, or similar) is a plus.
Work Environment
This is an on-site position, Monday through Friday, in Puerto Rico. Occasional travel may be required.