Tittle: Quality Assurance Specialist – PRQN-768

Location: Juncos, Puerto Rico

Work Schedule: Onsite – Administrative Shift

Availability: Must be available to work different shifts and/or weekends as business needs require

Positions Available: 1

Contract Duration: 6 months

Important Notice

This opportunity is available only to direct individual candidates. Third-party contractors, staffing agencies, vendors, and Corp-to-Corp (C2C) arrangements will not be considered for this position.

Position Summary

Our client is seeking a Quality Assurance professional to support its Quality Assurance program with minimal supervision. The selected candidate will provide hands-on quality oversight across manufacturing, validation, quality systems, facilities, environmental programs, and new product introduction activities.

The role requires strong technical knowledge, independent decision-making, cross-functional collaboration, and the ability to lead quality initiatives and investigations in a regulated manufacturing environment.

Key Responsibilities

• Review and approve product Manufacturing Procedures (MPs).
• Review and approve process validation protocols and reports for manufacturing processes.
• Participate as a Quality representative on incident triage teams.
• Review and approve Environmental Characterization reports.
• Support the release of sanitary utility systems.
• Review and approve planned incidents.
• Represent Quality Assurance on New Product Introduction (NPI) teams.
• Lead quality investigations and ensure appropriate root-cause analysis, corrective actions, and closure.
• Lead and support site audits.
• Own and maintain site Quality program procedures.
• Serve as the QA Manager's designee on the local Change Control Review Board (CCRB).
• Review and assess Quality Risk Assessments.
• Support automation-related Quality activities.
• Support facilities and environmental programs.
• Review and approve Work Orders as required.
• Review and approve EMS/BMS alarms.
• Review and approve Nonconformance (NC) investigations and CAPA records.
• Review and approve change controls.
• Provide lot disposition and authorize lots for shipment.
• Support compliance with applicable cGMP requirements, Quality Systems, and established procedures.
• Collaborate with Manufacturing, Process Development, Validation, Quality Control, Engineering, Facilities, Environmental, Warehouse, and other cross-functional teams.
• Support internal and external audits and regulatory inspections as required.
• Identify and evaluate compliance, product quality, and supply risks.
• Support continuous improvement initiatives and quality-related projects.

Education & Experience

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

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

Required Knowledge & Skills

• Strong knowledge and experience in Quality Assurance, Quality Systems, manufacturing, distribution, validation, and process development.
• Experience working in regulated manufacturing environments and within cGMP requirements.
• Strong project management and organizational skills, with the ability to manage assignments through completion.
• Demonstrated ability to initiate and lead cross-functional teams.
• Strong leadership, influencing, facilitation, and negotiation skills.
• Ability to work independently while effectively interacting with employees and leaders at all organizational levels.
• Strong written and verbal communication skills in English and Spanish.
• Strong presentation, facilitation, database, spreadsheet, and word-processing skills.
• Advanced data trending and evaluation capabilities.
• Ability to identify, assess, and address compliance issues.
• Demonstrated ability to interact effectively with regulatory agencies.
• Strong understanding of Quality Systems, including deviations, CAPA, change control, risk assessments, and validation.
• Experience supporting New Product Introduction (NPI) and complex quality projects.
• Experience with commissioning and qualification activities.
• Experience with GxP applications and/or Computer System Validation (CSV) or Computer System Quality Assurance (CSQA), particularly within regulated industries.
• Experience developing, reviewing, or approving validation documentation, including:
• Validation Master Plans (VMP)
• Risk/GxP Assessments
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Validation protocols and test scripts
• Validation completion and summary reports

Quality Systems & Manufacturing Experience

The ideal candidate will have hands-on experience with Quality Systems and manufacturing processes, including:

• On-the-floor Plant Quality Assurance (PQA)
• Batch record review
• Manufacturing processes, procedures, and testing methods
• MES and Electronic Batch Records (EBR)
• SAP
• EDMQ
• DQMS
• TrackWise
• Deviations and investigations
• CAPA
• Change controls
• Validation
• Manufacturing and distribution processes
• Quality Assurance and Quality Laboratory (QAL) processes
• Process Development
• New Product Introduction (NPI)
• Commissioning and Qualification (C&Q)



Additional Responsibilities & Expectations

• Ensure production records and testing results are complete, accurate, and compliant with written procedures and cGMP requirements.
• Ensure deviations are properly investigated, documented, and managed according to established procedures.
• Support on-the-floor deviation triage and ensure appropriate deviation records are initiated.
• Ensure changes with potential product quality impact are appropriately assessed and managed.
• Provide Quality oversight for complex projects involving new products.
• Support internal and external audits and inspections and serve as a Quality Unit representative when required.
• Maintain compliance with assigned training requirements before performing applicable tasks.
• Champion continuous improvement initiatives, programs, and projects.
• Provide Quality support and oversight for NPI activities.
• Serve as a strategic Quality resource regarding quality, compliance, supply, and safety risks.
• Collaborate effectively with Manufacturing, Quality Systems, Process Development, Validation, Quality Control, Engineering, Facilities, Environmental, Warehouse, Contractors, and other support functions.