QA Specialist – ProQN-669

Location: Juncos, Puerto Rico

Work Schedule: On-site, non-standard shift; must be available to work different shifts and/or weekends based on business needs

Position Available: 1

Important Notice

This opportunity is available only to individual candidates. Third-party contractor submissions, staffing vendors, and Corp-to-Corp (C2C) arrangements will not be considered.

Position Summary

Our client is seeking a QA Specialist to support its Quality Assurance program with minimal supervision. The successful candidate will provide on-the-floor Quality Assurance support, oversee cGMP compliance, review and approve manufacturing documentation, support investigations and validation activities, and collaborate with cross-functional teams to maintain product quality and regulatory compliance.

Minimum Qualification

• Bachelor’s degree in Science or Engineering with 4 years of directly related experience.

Key Responsibilities

• Perform on-the-floor Plant Quality Assurance (PQA) review, approval, and tracking of cGMP processes, procedures, testing methods, manufacturing documentation, records, and batch records.
• Work with quality and manufacturing systems, including MES, EBR, SAP, EDMQ, DQMS, and TrackWise, as applicable.
• Review and approve product manufacturing procedures (MPs).
• Approve process validation protocols and reports for manufacturing processes.
• Support incident triage activities and ensure appropriate Quality involvement.
• Lead and support investigations, including deviations, nonconformances, and CAPA records.
• Ensure deviations from established procedures are appropriately investigated, documented, and managed according to applicable procedures.
• Conduct or support on-the-floor triage and ensure procedural controls are maintained.
• Verify that production records and testing results are complete, accurate, and compliant with written procedures and cGMP requirements.
• Review and approve planned incidents, change controls, risk assessments, and CAPA records.
• Approve Environmental Characterization reports.
• Support the release of sanitary utility systems.
• Provide lot disposition and authorize lots for shipment.
• Represent QA on New Product Introduction (NPI) teams and provide quality oversight for new products.
• Support continuous improvement initiatives, programs, and projects.
• Support automation, facilities, environmental, and related quality activities.
• Review and approve Work Orders and EMS/BMS alarms.
• Serve as a QA representative on cross-functional teams involving Quality Management Systems, Manufacturing, Process Development, Validation, Quality Control, Warehouse, Engineering, Contractors, Environmental, and Facilities.
• Support internal and external audits and inspections and serve as a Quality Unit representative when required.
• Lead site audits and maintain ownership of assigned site quality procedures and programs.
• Serve as a designee for the QA Manager on the local Change Control Review Board (CCRB), as applicable.
• Serve as a Quality contact for complex projects involving new products.
• Provide quality and compliance guidance to senior management regarding quality, compliance, supply, and safety risks.
• Ensure assigned training requirements are completed before performing applicable tasks.

Preferred Qualifications

Candidates who demonstrate the following qualifications and experience will stand out:

• Demonstrated expertise in Quality Systems, particularly deviations, CAPA, and change control.
• Experience with computer systems validation (CSV) or computer systems quality assurance (CSA/CSQA), particularly within regulated environments.
• Experience supporting medical device environments and/or consulting projects.
• Strong knowledge of manufacturing and distribution processes, Quality Assurance, Quality Laboratory (QAL), validation, and Process Development.
• Experience validating GxP applications, including:
• Validation Master Plans
• Installation Qualification (IQ)
• Risk Assessments/GxP Assessments
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Validation protocols and test scripts
• Validation completion and summary reports
• Experience with commissioning and qualification activities.
• Experience serving as a Quality contact for complex projects involving new products.
• Strong understanding of cGMP requirements and regulated manufacturing environments.
• Ability to identify, assess, and address compliance issues.
• Advanced data trending and evaluation skills.
• Strong project management and organizational skills.
• Ability to lead and influence cross-functional teams and effectively negotiate solutions.
• Ability to work independently while collaborating effectively with employees and leaders at all organizational levels.
• Demonstrated ability to interact effectively with regulatory agencies.
• Strong proficiency with word processing, presentation, database, and spreadsheet applications.
• Strong written and verbal communication, facilitation, and presentation skills in English and Spanish.

Education Requirements

Candidates must meet one of the following education and experience combinations:

• Doctorate; or
• Master’s degree plus 2 years of directly related experience; or
• Bachelor’s degree plus 4 years of directly related experience; or
• Associate degree plus 8 years of directly related experience; or
• High school diploma/GED plus 10 years of directly related experience.

Core Competencies

• Project management
• Quality Systems and cGMP compliance
• Manufacturing and distribution processes
• Quality Assurance and Quality Laboratory processes
• Validation and Process Development
• Deviation, CAPA, and change control management
• Risk assessment and compliance evaluation
• Cross-functional team leadership
• Strong organizational and follow-through skills
• Leadership, influence, and negotiation
• Data trending and analysis
• Regulatory agency interaction
• Audit and inspection support
• Strong written and verbal communication
• Facilitation and presentation skills
• Ability to work independently and collaborate across organizational levels
• Proficiency with standard word processing, presentation, database, and spreadsheet applications

Key Functional Areas

The QA Specialist will be expected to support or lead activities including:

• Product manufacturing procedure (MP) review and approval
• Process validation protocol and report approval
• Incident triage and planned incident approval
• Environmental Characterization report approval
• Sanitary utility system release
• NPI Quality representation
• Investigation leadership
• Site audits
• Site Quality Program procedures
• Local Change Control Review Board (CCRB) representation
• Risk Assessment review
• Automation support
• Facilities and Environmental program support
• Work Order review and approval
• EMS/BMS alarm review and approval
• Nonconformance and CAPA approval
• Change Control approval
• Lot disposition and shipment authorization

Work Environment

This is an on-site position in Juncos, Puerto Rico with a non-standard work schedule. Candidates must be flexible and available to work different shifts and/or weekends based on business needs.