QA Specialist ProQN670

ProQuality Network; Puerto Rico; Hybride; USD 60 000 - 85 000; Plein temps

Résumé du poste

ProQuality Network is seeking a Specialist QA to support the Quality Assurance program with minimal supervision. You will perform diverse quality activities across manufacturing, validation, investigations, documentation, and compliance.

The role requires experience in change control, documentation review, process validation, and PPQ, with responsibilities spanning MPs, CAPA, incident triage, NPI participation, and release of systems. Hybrid schedule in Puerto Rico is expected.

Qualifications

• Excellent organizational skills and ability to manage assignments end-to-end.
• Ability to initiate and lead cross-functional teams.
• Strong leadership, influencing, and negotiation skills.
• Proficiency with standard office software (word processing, spreadsheets, presentations).

Responsabilités

• Review and approve product Master Plans (MPs).
• Approve process validation protocols and reports for manufacturing processes.
• Participate as QA representative on incident triage teams.
• Review and approve Environmental Characterization reports.
• Release sanitary utility systems.
• Review and approve planned incidents.
• Represent QA on New Product Introduction (NPI) teams.
• Lead quality investigations.
• Own and maintain site Quality Program procedures.
• Serve as QA Manager's designee on CCRB.
• Support automation-related activities.
• Support Facilities and Environmental programs.
• Review and approve Work Orders.
• Review and approve EMS/BMS alarms.
• Approve NC investigations and CAPA records.
• Review and approve Change Controls.
• Provide lot disposition and authorize lots for shipment.

Connaissances

Organizational skills

Cross-functional teamwork

Leadership

Communication

Formation

Master's degree + 2 years related experience

Bachelor's degree + 4 years related experience

Associate degree + 8 years related experience

High school diploma/GED + 10 years related experience

Description du poste

Work Schedule: Hybrid | Administrative Shift

Eligibility: Puerto Rico Residents Only

Positions Available: 1

Contract Duration: 5 months

Summary

Our client is seeking a Specialist QA to support the Quality Assurance program with minimal supervision. The selected candidate will perform a variety of quality-related activities involving manufacturing, validation, investigations, documentation, compliance, and cross-functional support.

Preferred Qualifications

• Change Control experience
• Documentation Review experience
• Process Validation experience
• PPQ experience

ey Responsibilities

• Review and approve product Master Plans (MPs).
• Approve process validation protocols and reports for manufacturing processes.
• Participate as the Quality representative on incident triage teams.
• Review and approve Environmental Characterization reports.
• Release sanitary utility systems.
• Review and approve planned incidents.
• Represent Quality Assurance on New Product Introduction (NPI) teams.
• Lead quality investigations.
• Own and maintain site Quality Program procedures.
• Serve as the QA Manager's designee on the local Change Control Review Board (CCRB).
• Support automation-related activities.
• Support Facilities and Environmental programs.
• Review and approve Work Orders.
• Review and approve EMS/BMS alarms.
• Approve Non-Conformance (NC) investigations and CAPA records.
• Review and approve Change Controls.
• Provide lot disposition and authorize lots for shipment.

Education Requirements

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 degree plus 8 years of directly related experience; or
• High school diploma/GED plus 10 years of directly related experience.
• Excellent organizational skills, with the ability to manage assignments and follow them through to completion.
• Ability to initiate and lead cross-functional teams.
• Strong leadership, influencing, and negotiation skills.
• Strong knowledge and expertise in the applicable area of responsibility.
• Ability to collaborate and coordinate effectively with higher-level external resources.
• Strong knowledge of and experience with manufacturing and distribution processes, Quality Assurance (QA), Quality Assurance Laboratory (QAL), validation, and process development.
• Ability to interact effectively with regulatory agencies.
• Proficiency with word processing, presentation, database, and spreadsheet applications.
• Strong written and verbal communication, facilitation, and presentation skills.
• Ability to work independently and interact effectively with employees and stakeholders at various organizational levels.
• Advanced data trending and evaluation skills.
• Ability to evaluate compliance issues and determine appropriate actions.