Quality Assurance Specialist- PRQN768

Frey Consulting Group; Juncos (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

Frey Consulting Group seeks a Quality Assurance professional to provide hands-on oversight across manufacturing, validation, quality systems, facilities, environmental programs, and new product introduction activities.

The candidate will lead quality initiatives, investigations, and cross-functional collaborations in a regulated manufacturing environment with strong English and Spanish communication skills.

Qualifications

• Quality Assurance experience in regulated manufacturing.

Responsibilities

• Review and approve MPs and validation protocols.

Skills

Quality Assurance

Cross-functional collaboration

Project management

Communication (English/Spanish)

Independent decision making

Education

Master's degree

Bachelor's degree

Associate's degree

High school diploma

Tools

SAP

EDMQ

DQMS

TrackWise

C&Q/CSV/CSQA

Job description

Tittle: Quality Assurance Specialist – PRQN-768

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

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:

• 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.
• Risk/GxP Assessments
• 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.