Quality Assurance Specialist PRQN807

Loxo; Juncos (PR); Hybrid; USD 85,000 - 110,000; Full time

Job summary

Loxo is seeking a Quality Assurance professional to support its QA program with minimal supervision. The selected candidate will provide QA oversight across manufacturing, validation, environmental, facilities, and quality systems while partnering closely with cross-functional teams.

The role requires strong GMP knowledge, experience with change controls, CAPAs, and risk assessments, plus ability to lead audits and investigations in a regulated manufacturing environment.

Qualifications

• Must meet one of the listed education/experience combinations.
• Strong project management and ability to lead cross-functional teams.
• Excellent written and verbal communication skills.
• GMP knowledge and regulated manufacturing experience.
• Proficiency with word processing, spreadsheets, and database applications.

Responsibilities

• Review and approve MPs.
• Review and approve process validation protocols and reports for manufacturing processes.
• Participate as QA representative on incident triage teams.
• Review and approve Environmental Characterization reports.
• Support release of sanitary utility systems.
• Review and approve planned incidents.
• Represent QA on New Product Introduction teams.
• Lead quality investigations and site audits.
• Own and maintain site Quality program procedures.
• Serve as QA Manager designee for the CCRB.
• Review risk assessments.
• Support automation-related activities.
• Support facilities and environmental programs.
• Review and approve work orders and EMS/BMS alarms.

Skills

Project management

Cross-functional teams

Leadership

Quality Assurance

GMP

Regulatory

Data trending

Education

Doctorate

Master’s degree

Bachelor’s degree

Associate degree

High school diploma

Strong project management

Job description

Work Schedule:

Hybrid – Administrative Shift, Schedule Requirements

Candidates must be available to support different shifts and/or weekends based on business needs.

Contract Duration:

5 months

Position Available:

1

Important Notice:

This opportunity is available only to direct individual candidates. Submissions from third-party contractors, staffing agencies, vendors, or Corp-to-Corp (C2C) arrangements will not be considered.

Position Summary

Our client is seeking a Quality Assurance professional to support its Quality Assurance program with minimal supervision. The selected candidate will provide quality oversight across manufacturing, validation, environmental, facilities, and quality systems activities while partnering closely with cross-functional teams.

Key Responsibilities

• Review and approve Master Production Records (MPs).
• Review and approve process validation protocols and reports for manufacturing processes.
• Participate as a Quality representative on incident triage teams.
• Review and approve Environmental Characterization reports.
• Support the release of sanitary utility systems.
• Review and approve planned incidents.
• Represent Quality Assurance on New Product Introduction (NPI) teams.
• Lead quality investigations.
• Lead and support site audits.
• Own and maintain site Quality program procedures.
• Serve as the QA Manager designee for 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 Nonconformance (NC) investigations and CAPA records.
• Review and approve change controls.
• Support lot disposition and authorize lots for shipment.

Education & Experience

Candidates must meet one of the following educational and experience combinations:

• Doctorate in a relevant field.
• Master’s degree plus 2 years of directly related experience.
• Bachelor’s degree plus 4 years of directly related experience.
• Associate degree plus 8 years of directly related experience.
• High school diploma/GED plus 10 years of directly related experience.
• Strong project management and organizational skills, with the ability to manage assignments through completion.
• Ability to initiate and lead cross-functional teams.
• Strong leadership, influencing, facilitation, and negotiation skills.
• Strong technical knowledge within the Quality Assurance area.
• Ability to collaborate and coordinate effectively with senior-level internal and external resources.
• Strong knowledge and experience with manufacturing and distribution processes, Quality Assurance, Quality Laboratory, validation, and process development.
• Ability to interact effectively with regulatory agencies.
• Proficiency with word processing, presentation, database, and spreadsheet applications.
• Excellent written and verbal communication skills.
• Ability to work independently while effectively interacting with employees at various organizational levels.
• Strong data trending and evaluation capabilities.
• Ability to assess and evaluate compliance issues.
• Strong understanding of GMP and regulated manufacturing environments.

Preferred Qualifications

• GMP manufacturing experience within Quality Assurance.
• Experience reviewing and approving change controls, deviations, CAPAs, protocols, reports, and procedures.
• Experience supporting packaging and inspection operations.
• Strong knowledge of Good Documentation Practices (GDP).
• Experience working with electronic quality systems.
• Ability to collaborate effectively with Manufacturing, Engineering, and Process Development teams.
• Strong English and Spanish communication skills are preferred.