QA Specialist (3122643)
Job Title: Specialist QA (3122643)
Location: East of Puerto Rico (Open for Puerto Rico Residents)
Work Mode: Hybrid/Remote on Administrative Shift
Positions Available: 1
Duration: Approximately Five Months
Summary
The Specialist QA will perform various duties and responsibilities in support of our client’s Quality Assurance program under minimal supervision. The selected candidate will ensure compliance with regulatory standards, oversee quality processes, and support manufacturing and inspection activities.
Preferred Qualifications
Technical Skills:
- Proficiency in Quality Management Systems
- Experience with inspection processes (automatic and manual)
- Knowledge of equipment, including engineering characterizations and system validations
- Strong data analysis skills
- Understanding of manufacturing processes
- Expertise in document review and management
Soft Skills:
- Attention to detail
- Critical and analytical thinking
- Cross-functional collaboration
- Strong communication skills
Key Responsibilities
- Review and approve product Master Production records (MPs).
- Approve process validation protocols and reports for manufacturing processes.
- Serve as a Quality representative in incident triage teams.
- Approve Environmental Characterization reports.
- Oversee the release of sanitary utility systems.
- Approve planned incidents.
- Represent Quality Assurance in New Product Introduction (NPI) teams.
- Lead investigations and site audits.
- Own and manage site quality program procedures.
- Act as a designee for the QA Manager on the local Change Control Review Board (CCRB).
- Review and assess risk assessments.
- Support automation activities.
- Contribute to facilities and environmental programs.
- Review and approve work orders.
- Monitor and approve Environmental Monitoring System (EMS) and Building Management System (BMS) alarms.
- Approve Non-Conformance (NC) investigations and Corrective and Preventive Action (CAPA) records.
- Approve change controls.
- Provide lot disposition and authorize product shipments.
Education & Experience Requirements
Candidates must meet one of the following educational and experience requirements:
- Doctorate Degree with relevant experience
- Master’s Degree and at least 3 years of directly related experience
- Bachelor’s Degree and at least 5 years of directly related experience
- Associate’s Degree and at least 10 years of directly related experience
- High School Diploma/GED and at least 12 years of directly related experience
- Preferred Background: Engineering or Life Sciences
- Preferred Experience: Previous experience in a Quality Assurance role
Competencies & Skills
- Strong project management and organizational skills
- Ability to lead and influence cross-functional teams
- Strong leadership, negotiation, and collaboration abilities
- Extensive knowledge of manufacturing, distribution, validation, and process development
- Experience interacting with regulatory agencies
- Proficiency in word processing, presentations, databases, and spreadsheets
- Excellent communication (written and verbal), facilitation, and presentation skills
- Ability to work independently and interact effectively at all levels
- Advanced data trending and evaluation skills
- Ability to assess and address compliance issues
This is an exciting opportunity to be part of a dynamic team that directly contributes to ensuring product quality and regulatory compliance. If you meet the qualifications and are ready to take on this challenge, we invite you to apply today inside the job description link with an updated resume.