QA Specialist ProQN845

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

Job summary

ProQualityNetwork in Juncos, Puerto Rico, seeks a QA professional to support the client's QA program on-site for a 3-month contract. You will review MPs, validation protocols, and CAPA, while representing QA on the NPI team and leading investigations.

The role requires strong leadership, cross-functional collaboration, and experience in manufacturing QA, regulatory interfaces, and risk assessments. Availability for multiple shifts onsite is required, with a focus on quality assurance and

Qualifications

• Candidates must meet one of the education/experience options.
• Experience in QA, validation, and manufacturing environment.
• Proven ability to lead cross-functional teams.

Responsibilities

• Review and approve MPs.
• Review and approve validation protocols and reports for manufacturing processes.
• Serve as a QA representative on the Incident Triage Team.
• Review and approve Environmental Characterization reports.
• Support the release of sanitary utility systems.
• Review and approve planned incidents.
• Represent QA on the New Product Introduction (NPI) team.
• Lead investigations and 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 risk assessments.
• Support automation-related activities, facilities programs, and environmental programs.
• Review and approve EMS and BMS alarms.
• Review and approve Nonconformance (NC) investigations and CAPA records.
• Review and approve change controls.
• Determine lot disposition and authorize lots for shipment.

Skills

Project management

Cross-functional leadership

QA knowledge

Validation planning

Change control

Regulatory liaison

Data trending

Communication

Independent work

Education

Master's degree

Bachelor's degree

Associate degree

High school diploma

Job description

Location: Juncos, Puerto Rico (Open to Puerto Rico residents only)

Work Schedule: Onsite, Administrative Shift; must be available to work different shifts based on business needs

Contract Duration: 3 months

Positions Available: 1

SUMMARY

Perform one or more of the following duties and responsibilities in support of our client's Quality Assurance program, working under minimal supervision.

PREFERRED QUALIFICATIONS

• New Product Introduction (NPI)
• Change Control
• Factory Acceptance Tests (FATs)
• Validation
• Process Performance Qualification (PPQ)

FUNCTIONS

• Review and approve product Manufacturing Procedures (MPs).
• Review and approve process validation protocols and reports for manufacturing processes.
• Serve as a Quality representative on the Incident Triage Team.
• Review and approve Environmental Characterization reports.
• Support the release of sanitary utility systems.
• Review and approve planned incidents.
• Represent Quality Assurance (QA) on the New Product Introduction (NPI) team.
• Lead investigations and 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 risk assessments.
• Support automation-related activities, facilities programs, and environmental programs.
• Review and approve work orders and Environmental Monitoring System (EMS) and Building Management System (BMS) alarms.
• Review and approve Nonconformance (NC) investigations and Corrective and Preventive Action (CAPA) records.
• Review and approve change controls.
• Determine lot disposition and authorize lots for shipment.

EDUCATION

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

• Master's degree and at least 2 years of directly related experience.
• Bachelor's degree and at least 4 years of directly related experience.
• Associate degree and at least 8 years of directly related experience.
• High school diploma or GED and at least 10 years of directly related experience.

COMPETENCIES/SKILLS

• Strong project management and organizational skills, with the ability to manage assignments and ensure timely completion.
• Ability to initiate, lead, and coordinate cross-functional teams.
• Strong leadership, influencing, negotiation, and collaboration skills.
• In-depth knowledge of the relevant area of expertise.
• Ability to collaborate and coordinate effectively with senior-level personnel and external resources.
• Strong knowledge of and experience with manufacturing and distribution processes, Quality Assurance (QA), Quality Assurance Laboratories (QAL), validation, and process development.
• Ability to interact effectively with regulatory agencies.
• Proficiency in word processing, presentation, database, and spreadsheet applications.
• Excellent written and verbal communication, facilitation, and presentation skills.
• Ability to work independently and interact effectively with personnel at various organizational levels.
• Advanced data trending and evaluation skills.
• Ability to assess compliance issues and support appropriate resolution.
• Ability to demonstrate our client's core values and leadership practices.