Sr Quality Assurance Scientist - MES Project

Inteldot has over 15 years in the life science industry with allocations across Puerto Rico, the United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

Administrative shift (flexible hours based on business needs)

Position Overview

We are seeking an experienced Senior Quality Assurance (QA) Scientist to provide quality oversight and technical support for pharmaceutical manufacturing operations within a regulated GMP environment. The selected candidate will be responsible for providing Quality Assurance oversight at the manufacturing shop floor level, ensuring compliance with cGMP regulations, approved procedures, and established quality standards. Responsibilities include providing quality guidance and making risk-based decisions during manufacturing operations, reviewing and approving batch records, managing quality events, and supporting deviation investigations, CAPA, and Change Control activities. The position will also support warehouse operations, QC laboratories, inspection, packaging, and other GMP-related activities, ensuring product quality, operational compliance, and inspection readiness.

Required Qualifications

• Bachelor's degree in chemistry, Biology, Microbiology, Pharmacy, Engineering, or a related scientific discipline.
• Minimum of six (6) years of experience in pharmaceutical manufacturing or another GMP-regulated environment with direct Quality Assurance or quality-related responsibilities.
• Three (3) to five (5) years of practical experience with Quality Systems, including deviations, investigations, CAPA, and Change Control.
• Strong knowledge of pharmaceutical manufacturing operations, preferably involving sterile and parenteral products.
• In-depth knowledge of cGMP regulations, FDA requirements, applicable EU GMP regulations, and pharmaceutical quality standards.
• Demonstrated experience reviewing and approving GMP documentation, including batch records, deviation reports, SOPs, CAPAs, logbooks, and technical reports.
• Experience supporting deviation investigations, root cause analysis, impact assessments, and quality risk management.
• Ability to independently assess quality risks and make appropriate GMP decisions based on technical information, facts, and regulatory requirements.
• Strong understanding of Change Control, quality event management, and manufacturing compliance processes.
• Experience supporting manufacturing floor operations, quality oversight, and inspection readiness activities.
• Strong analytical, critical thinking, problem-solving, and decision-making skills.
• Excellent attention to detail and ability to manage multiple priorities in a fast-paced manufacturing environment.
• Ability to recognize critical quality issues and determine when escalation to Subject Matter Experts (SMEs) or senior management is necessary.
• Strong interpersonal, organizational, and cross-functional collaboration skills.
• Fully bilingual in English and Spanish, with excellent written and verbal communication skills.
• Proficiency in Microsoft Office and pharmaceutical quality systems such as TrackWise/Infinity and SAP.

Preferred Qualifications

• Direct experience providing QA oversight in sterile pharmaceutical or biologics manufacturing operations.
• Experience supporting parenteral manufacturing, including aseptic processing and contamination control practices.
• Experience reviewing and approving manufacturing batch records and supporting product disposition activities.
• Knowledge of Media Fill operations, process validation, equipment qualification, and manufacturing process controls.
• Experience supporting finished product inspection, packaging operations, and visual inspection activities.
• Experience participating in regulatory inspections and internal GMP audits.
• Familiarity with Annual Product Review (APR) processes and quality trend analysis.
• Experience delivering GMP training and coaching manufacturing personnel on quality and compliance requirements.
• Experience leading quality improvement initiatives and promoting right-first-time manufacturing practices.

Key Responsibilities

• Provide QA oversight of manufacturing and GMP operational activities, ensuring compliance with approved procedures, cGMP regulations, and established quality standards.
• Conduct routine shop floor walkthroughs and operational assessments to verify adherence to GMP requirements, identify compliance gaps, and maintain inspection readiness.
• Provide Quality Assurance guidance and make risk-based decisions regarding planned and unplanned manufacturing events, deviations, and quality-related issues.
• Evaluate operational risks and determine appropriate actions, including escalation and continuation or interruption of manufacturing activities when necessary.
• Review and approve manufacturing batch records across applicable production stages to support product disposition and release activities.
• Review, assess, and approve deviation reports, ensuring appropriate evaluation of severity, frequency, detection methods, product impact, and regulatory implications.
• Lead or support deviation investigations, including root cause analysis, impact assessments, and preparation of comprehensive investigation reports.
• Review and approve Corrective and Preventive Action (CAPA) plans and deliverables, ensuring alignment with identified root causes and effective resolution of quality issues.
• Review and approve Standard Operating Procedures (SOPs), manufacturing procedures, specifications, technical reports, protocols, drawings, and other GMP-controlled documentation.
• Evaluate and provide QA input on Change Control requests, ensuring proposed changes maintain validated processes, regulatory compliance, and product quality.
• Support the implementation of new GMP practices, providing technical guidance and coaching to manufacturing personnel.
• Support maintenance, calibration, and qualification activities for manufacturing equipment and associated systems.
• Ensure appropriate monitoring and control of storage conditions for quarantined materials and products.
• Support inspection and packaging operations through sampling, visual inspection, and evaluation of finished product samples in accordance with approved specifications and procedures, when assigned.
• Support process validation, equipment qualification, and other validation activities through technical documentation review and approval.
• Participate in Media Fill activities, ensuring appropriate execution and compliance with established procedures, including routine and non-routine interventions.
• Support Annual Product Review (APR) activities through the assessment and analysis of quality events, deviations, and manufacturing trends.
• Perform quality data analysis to support investigations, technical assessments, Change Control, and continuous improvement initiatives.
• Prepare and deliver GMP training, Quality Talks, and technical communications to reinforce quality standards and share lessons learned.
• Manage audit observations, investigations, Change Controls, and CAPA records within applicable Quality Management Systems (QMS).
• Support internal audits, regulatory inspections, and agency interactions by providing technical documentation, quality assessments, and compliance guidance.
• Identify and lead continuous improvement initiatives to strengthen quality systems, operational performance, and right-first-time execution.
• Collaborate with Manufacturing, Engineering, MS&T, Supply Chain, QC, and other functional teams to ensure effective quality oversight and resolution of operational issues.

Key Deliverables

The selected resource will be responsible for reviewing, evaluating, approving, developing, and/or coordinating:

• Manufacturing Batch Records and supporting documentation for QA review and product disposition.
• Deviation Reports, investigation records, root cause analyses, and impact assessments.
• Corrective and Preventive Action (CAPA) plans, records, and effectiveness assessments.
• Change Control requests and associated quality impact assessments.
• Standard Operating Procedures (SOPs), GMP procedures, specifications, and controlled documentation.
• Validation, qualification, and Media Fill protocols and supporting reports.
• Annual Product Review (APR) inputs, quality event assessments, and supporting analyses.
• Audit observations, inspection readiness documentation, and regulatory compliance records.
• Quality risk assessments and operational GMP compliance evaluations.
• Finished product sampling, inspection, and evaluation records, when assigned to inspection and packaging operations.
• GMP training materials, Quality Talks, and lessons-learned communications.
• Quality metrics, trend analyses, and continuous improvement documentation.