QA Specialist ProQN845

ProQuality Network; Juncos (PR); On-site; USD 55,000 - 75,000; Part time

Job summary

ProQuality Network in Juncos, Puerto Rico is seeking a QA Manager to lead quality assurance activities under minimal supervision. The role focuses on reviewing MPs, validating processes, and representing QA on NPI teams.

You will own site QA procedures, lead investigations, coordinate with regulatory bodies, and ensure proper change control. This onsite, 3-month assignment requires strong leadership and process knowledge to support GMP manufacturing.

Qualifications

• Master's or higher degree with related field and experience in QA/QC
• Experience with GMP/GLP environments and regulatory interactions
• Experience leading cross-functional teams and quality investigations

Responsibilities

• Review and approve manufacturing procedures (MPs).
• Review and approve process validation protocols and reports.
• Lead QA representation on NPI teams and site change controls.
• Own and maintain site QA procedures.
• Lead investigations and site audits.
• Review risk assessments and CAPA records.
• Coordinate environmental monitoring and EMS/BMS alarms reviews.

Skills

Project management

Cross-functional leadership

Quality Assurance

Regulatory interaction

Communication skills

Data trending

Education

Master's degree in related field

Bachelor's degree in related field

Associate degree with 8 years experience

High school diploma with 10 years experience

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.