Title: Specialist QA ProQN670

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.
• Lead 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.
• 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:

• Doctorate degree; or
• 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.

Competencies & Skills

• Strong project management skills.
• 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.