QA Specialist- ProQN669

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

Job summary

Frey Consulting Group in Puerto Rico seeks a QA Specialist to support its Quality Assurance program with minimal supervision. The successful candidate will provide on-the-floor QA support, oversee cGMP compliance, review and approve manufacturing documentation, and collaborate with cross-functional teams to maintain product quality.

This role involves supporting investigations, CAPA, deviations, and change control, plus participation in audits and New Product Introduction teams.

Qualifications

• Bachelor’s degree in Science or Engineering with 4 years of directly related experience.
• Experience ensuring cGMP compliance and supporting QA investigations.
• Familiarity with quality systems and regulatory expectations.

Responsibilities

• Perform on-the-floor QA review, approval, and tracking of cGMP processes and batch records.
• Review and approve MPs, validation protocols and reports for manufacturing processes.
• Lead deviations, CAPA records, and investigations with cross-functional teams.
• Support audits, internal/external inspections, and New Product Introduction teams.
• Provide quality guidance to senior management on risks and regulatory compliance.

Skills

On-the-floor QA

cGMP compliance

Cross-functional collaboration

Investigations & CAPA

Regulatory compliance

Education

Bachelor’s degree in Science or Engineering

4 years directly related experience

Tools

MES

EBR

SAP

EDMQ

DQMS

TrackWise

Job description

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

Position Available: 1

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.

• 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.
• 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
• 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