Specialist QA 3422423

Title: Specialist QA

Location: East of Puerto Rico (Hybrid/Remote – Administrative Shift; open to Puerto Rico residents)

Positions Available: 1

Duration: Approximately one (1) year

Summary

The Specialist QA will perform a variety of duties and responsibilities in support of our client’s Quality Assurance program, working under minimal supervision. The role requires strong technical expertise, regulatory knowledge, and the ability to support cross-functional teams in a regulated manufacturing environment.

Preferred Qualifications

• Educational background in Sciences or Engineering.
• Quality professional with experience in Validations and Commissioning & Qualification (C&Q) of manufacturing equipment and laboratory bench equipment, including IOQ, PQ, and functional testing.
• Technical writing experience and strong knowledge of Quality Systems (Deviations, Change Control).
• Experience with Maintenance activities (Preventive Maintenance, Work Orders, Job Plans review and approval).
• Skilled in reviewing technical documentation, including Validation Reports, Procedures, and Forms.

Functions

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Serve as QA representative on incident triage team.
• Approve Environmental Characterization reports.
• Oversee the release of sanitary utility systems.
• Approve planned incidents.
• Represent QA on New Product Introduction (NPI) teams.
• Lead investigations and site audits.
• Own and maintain site quality program procedures.
• Act as designee for QA Manager on local CCRB.
• Review risk assessments.
• Support automation, facilities, and environmental programs.
• Review and approve Work Orders and EMS/BMS alarms.
• Approve nonconformance (NC) investigations and CAPA records.
• Review and approve change controls.
• Provide lot disposition and authorize lots for shipment.

Education

• Doctorate OR
• Master’s degree + 2 years of directly related experience OR
• Bachelor’s degree + 4 years of directly related experience OR
• Associate’s degree + 8 years of directly related experience OR
• High school diploma/GED + 10 years of directly related experience.

Competencies / Skills

• Strong project management and organizational skills, with the ability to complete assignments independently.
• Proven ability to initiate and lead cross-functional teams.
• Advanced skills in leadership, influence, and negotiation.
• In-depth knowledge of manufacturing, distribution, QA, QAL, validation, and process development processes.
• Experience interacting with regulatory agencies.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, databases, and spreadsheets).
• Strong communication (written and verbal), facilitation, and presentation skills.
• Ability to work independently and interact effectively across all organizational levels.
• Skilled in advanced data trending and evaluation.
• Ability to evaluate compliance issues and provide sound recommendations.
• Commitment to demonstrating our client’s Values and Leadership Practices.