QA Specialist- ProQN669

ProQuality Network; Juncos (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

ProQuality Network in Juncos, Puerto Rico, is hiring a QA Specialist to support its Quality Assurance program with minimal supervision. You will oversee cGMP compliance, review manufacturing documentation, support investigations, and collaborate with cross-functional teams to maintain product quality and regulatory compliance.

The role requires strong experience with QA systems, deviations, CAPA, and change control, plus familiarity with MES, SAP, and TrackWise.

Qualifications

• Bachelor’s degree in Science or Engineering with 4 years of directly related experience.
• Demonstrated expertise in Quality Systems, deviations, CAPA, and change control.
• Experience with computerized validation/QA in regulated environments.
• Experience with medical device environments or consulting projects.
• Strong knowledge of manufacturing and distribution processes, QA, validation, and Process Development.

Responsibilities

• Perform on-the-floor QA review, approval, and tracking of cGMP processes and documentation.
• Review and approve MPs and process validation protocols/reports.
• Lead investigations including deviations, nonconformances, and CAPA records.
• Ensure deviations are investigated and documented per procedures.
• Represent QA on cross-functional teams and support internal/external audits.

Skills

Quality Systems

Deviations

CAPA

Change Control

CSV/CSA/CSQA

Regulated environments

Cross-functional collaboration

Auditing

Data trending

Education

Doctorate

Master’s degree + 2 years experience

Bachelor’s degree + 4 years experience

Associate degree + 8 years experience

High school diploma/GED + 10 years experience

Tools

MES

EBR

SAP

EDMQ

DQMS

TrackWise

Job description

• Approve Environmental Characterization reports.
• Environmental Characterization report approval

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

• 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

• 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.