MANUFACTURING QUALITY ASSURANCE (QA) SPECIALIST

Weil Group, Inc; Puerto Rico; On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Bilingual work environment

Job summary

Weil Group, Inc is seeking an experienced Manufacturing Quality Assurance (QA) Specialist to provide direct, on-the-floor QA oversight for pharmaceutical manufacturing in a GMP setting. You will ensure production activities, equipment, documentation, and personnel practices meet cGMP and FDA requirements, with real-time guidance and risk assessments.

You will review batch records, support deviations and CAPA, and collaborate with Manufacturing, Engineering, Validation, and Quality teams to

Qualifications

• Bachelor's degree in Science, Engineering, Chemistry, Biology, Pharmaceutical Sciences, or related technical discipline.
• Extensive hands-on Quality Assurance experience supporting pharmaceutical or biopharmaceutical manufacturing operations.
• Direct, on-the-floor QA oversight in a GMP-regulated environment.
• Strong working knowledge of cGMP regulations, FDA requirements, and QA systems.
• Experience reviewing batch records, production documentation, and GMP-related records.
• Experience supporting deviations, investigations, root cause analysis, and CAPA processes.
• GDP, data integrity principles, change control familiarity, and strong communication in English and Spanish.

Responsibilities

• Provide direct QA support and oversight for daily pharmaceutical manufacturing operations in accordance with cGMP.
• Conduct floor walkthroughs and inspections to verify compliance with procedures and quality requirements.
• Monitor critical activities such as equipment prep, line clearance, material handling, and in-process controls.
• Verify batch records against SOPs and process parameters; escalate quality issues promptly.
• Support deviations, investigations, CAPA, and containment actions with cross-functional teams.
• Assist change controls and quality system improvements to strengthen compliance.

Skills

On-the-floor QA oversight

cGMP knowledge

GMP documentation

Problem solving

English/Spanish bilingual

Education

Bachelor's degree in Science/Engineering/Pharma

Tools

TrackWise

MES

Electronic batch records (EBR)

SAP

Job description

MANUFACTURING QUALITY ASSURANCE (QA) SPECIALIST

• Biotech/Pharmaceutical

Job Overview

We are seeking an experienced Manufacturing Quality Assurance (QA) Specialist to provide direct, on-the-floor quality oversight and support for pharmaceutical manufacturing operations within a GMP-regulated environment.

The ideal candidate will have extensive hands-on experience in pharmaceutical manufacturing quality assurance, ensuring that production activities, processes, equipment, documentation, and personnel practices comply with established procedures, regulatory requirements, and quality standards.

This position requires a strong presence on the manufacturing floor, providing real-time quality guidance, identifying potential compliance risks, supporting investigations, and collaborating with Manufacturing, Engineering, Validation, and Quality teams to maintain product quality and operational compliance.

Key Responsibilities

On-the-Floor Quality Assurance & Manufacturing Oversight

• Provide direct QA support and oversight for daily pharmaceutical manufacturing operations, ensuring compliance with current Good Manufacturing Practices (cGMP), approved procedures, and established quality standards.
• Perform routine manufacturing floor walkthroughs and inspections to verify compliance with operational procedures, documentation practices, and quality requirements.
• Monitor critical manufacturing activities, including equipment preparation, line clearance, material handling, production execution, and in-process controls, as applicable.
• Verify that manufacturing activities are performed according to approved batch records, Standard Operating Procedures (SOPs), and established process parameters.
• Identify, document, and escalation potential quality issues, procedural discrepancies, and GMP compliance risks.
• Provide real-time quality guidance and support to manufacturing personnel during routine operations and unexpected events.

Batch Record Review & Documentation Compliance

• Review manufacturing batch records, electronic records, logbooks, and associated production documentation for accuracy, completeness, and GMP compliance.
• Verify adherence to Good Documentation Practices (GDP) and applicable data integrity requirements.
• Identify documentation discrepancies, missing information, and procedural inconsistencies, coordinating timely resolution with Manufacturing personnel.
• Support batch record reconciliation, manufacturing documentation review, and batch disposition activities within assigned responsibilities.
• Ensure that manufacturing records accurately reflect executed operations and maintain appropriate traceability.

Deviations, Investigations & CAPA

• Support the identification, documentation, and investigation of manufacturing deviations, nonconformances, and quality events.
• Collaborate with Manufacturing and technical teams to evaluate potential product quality impacts and determine appropriate containment actions.
• Participate in root cause investigations using established problem-solving methodologies.
• Review and support the implementation of Corrective and Preventive Actions (CAPA) to address identified quality issues.
• Monitor the effectiveness of corrective actions and support timely closure of quality events.
• Provide QA input regarding manufacturing discrepancies, procedural deviations, and potential compliance risks.

Change Control & Quality Systems

• Support the evaluation and implementation of change controls affecting manufacturing processes, equipment, materials, facilities, and operational procedures.
• Review proposed changes to assess potential impacts on product quality, regulatory compliance, and validated processes.
• Collaborate with Engineering, Validation, and Manufacturing teams to ensure appropriate quality oversight during process modifications and equipment-related activities.
• Support the review and revision of SOPs, manufacturing instructions, and other controlled documents.
• Participate in quality system improvement initiatives to strengthen manufacturing compliance and operational efficiency.

GMP Compliance, Audits & Continuous Improvement

• Ensure manufacturing activities comply with applicable FDA regulations, including 21 CFR Parts 210 and 211, and established cGMP requirements.
• Support internal audits, regulatory inspections, and quality assessments related to manufacturing operations.
• Identify opportunities to improve GMP compliance, documentation practices, and manufacturing quality performance.
• Provide quality guidance to manufacturing personnel regarding procedural compliance, documentation expectations, and quality standards.
• Participate in cross-functional meetings to address manufacturing quality concerns, operational challenges, and continuous improvement initiatives.
• Promote a strong quality culture through proactive communication, risk identification, and consistent application of quality requirements.

Qualifications & Requirements

Mandatory Qualifications

• Bachelor's degree in Science, Engineering, Chemistry, Biology, Pharmaceutical Sciences, or a related technical discipline.
• Extensive hands-on Quality Assurance experience supporting pharmaceutical or biopharmaceutical manufacturing operations.
• Demonstrated experience providing direct, on-the-floor QA oversight in a GMP-regulated manufacturing environment.
• Strong working knowledge of cGMP regulations, FDA requirements, and pharmaceutical manufacturing quality systems.
• Experience reviewing manufacturing batch records, production documentation, and GMP-related records.
• Experience supporting manufacturing deviations, investigations, root cause analysis, and CAPA processes.
• Working knowledge of change control, Good Documentation Practices (GDP), and data integrity principles.
• Ability to evaluate manufacturing quality issues, identify compliance risks, and communicate appropriate actions.
• Strong analytical, problem-solving, technical writing, and organizational skills.
• Ability to work independently and effectively collaborate with Manufacturing, Engineering, Validation, and Quality teams.
• Excellent communication skills in English and Spanish.
• Ability to work directly in manufacturing areas and support operational schedules as required.

Preferred Qualifications

• Previous experience supporting commercial pharmaceutical or biopharmaceutical manufacturing operations.
• Experience providing QA oversight for sterile or aseptic manufacturing processes.
• Familiarity with manufacturing equipment qualification, process validation, and cleaning validation activities.
• Experience with electronic batch records (EBR), Manufacturing Execution Systems (MES), and electronic quality management systems.
• Familiarity with quality systems such as TrackWise, SAP, or similar GMP-regulated platforms.
• Experience participating in FDA inspections, internal audits, or regulatory compliance assessments.
• Knowledge of manufacturing process controls, equipment cleaning, environmental monitoring, and contamination control practices.
• Experience supporting manufacturing investigations, product impact assessments, and batch disposition processes.

*Weil Group is proud to be an Equal Employment Opportunity Employer.*